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Trial record 1 of 1 for:    NCT02211261
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A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02211261
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Type 2 Diabetes Mellitus
Interventions Biological: PF-06293620
Biological: Placebo
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Period Title: Overall Study
Started 9 6 6 6 9 2 6 8 8 16 8
Completed 9 6 5 6 7 1 6 7 8 14 8
Not Completed 0 0 1 0 2 1 0 1 0 2 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             2             0             0             0             0             0             0
Other             0             0             0             0             0             1             0             0             0             2             0
Lost to Follow-up             0             0             0             0             0             0             0             1             0             0             0
Arm/Group Title Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts) Total
Hide Arm/Group Description One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. Total of all reporting groups
Overall Number of Baseline Participants 9 6 6 6 9 2 6 8 8 16 8 84
Hide Baseline Analysis Population Description
Baseline analysis population included all participants enrolled.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 9 participants 2 participants 6 participants 8 participants 8 participants 16 participants 8 participants 84 participants
<18 years 0 0 0 0 0 0 0 0 0 0 0 0
18-44 years 0 0 0 0 1 1 1 0 0 0 0 3
45-64 years 7 4 4 6 6 1 5 7 4 9 8 61
>=65 years 2 2 2 0 2 0 0 1 4 7 0 20
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 9 participants 2 participants 6 participants 8 participants 8 participants 16 participants 8 participants 84 participants
Female
5
  55.6%
1
  16.7%
4
  66.7%
3
  50.0%
4
  44.4%
0
   0.0%
0
   0.0%
4
  50.0%
3
  37.5%
9
  56.3%
1
  12.5%
34
  40.5%
Male
4
  44.4%
5
  83.3%
2
  33.3%
3
  50.0%
5
  55.6%
2
 100.0%
6
 100.0%
4
  50.0%
5
  62.5%
7
  43.8%
7
  87.5%
50
  59.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 9 participants 2 participants 6 participants 8 participants 8 participants 16 participants 8 participants 84 participants
Hispanic or Latino
6
  66.7%
5
  83.3%
2
  33.3%
4
  66.7%
3
  33.3%
2
 100.0%
4
  66.7%
2
  25.0%
4
  50.0%
7
  43.8%
7
  87.5%
46
  54.8%
Not Hispanic or Latino
3
  33.3%
1
  16.7%
4
  66.7%
2
  33.3%
6
  66.7%
0
   0.0%
2
  33.3%
6
  75.0%
4
  50.0%
9
  56.3%
1
  12.5%
38
  45.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
Hide Description An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Time Frame Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received any amount of dose of study medication.
Arm/Group Title Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 9 6 6 6 9 2 6 8 8 16 8
Measure Type: Number
Unit of Measure: participants
All-causality AE 5 3 3 5 5 0 3 4 4 11 8
All-causality SAE 0 1 0 0 0 0 0 0 0 1 2
Treatment-related AE 1 0 0 3 3 0 1 1 1 4 5
Treatment-related SAE 0 0 0 0 0 0 0 0 0 0 0
2.Primary Outcome
Title Number of Participants With Dose Limiting or Intolerable Adverse Events
Hide Description Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
Time Frame Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected.
Arm/Group Title Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants With Positive Anti-drug Antibody (ADA) Result
Hide Description ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive.
Time Frame Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received any amount of dose of study medication.
Arm/Group Title Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 9 6 6 6 9 2 6 8 8 16 8
Measure Type: Number
Unit of Measure: participants
1 5 2 1 2 0 1 0 5 7 4
4.Secondary Outcome
Title Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
Hide Description AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 1 5 6 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour/milliliter (mcg*hr/mL)
300 [1] 
(NA%)
1716
(46%)
6306
(54%)
19440
(56%)
6775
(12%)
[1]
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
5.Secondary Outcome
Title Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
Hide Description AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 1 5 6 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*hr/mL/mg
12.00 [1] 
(NA%)
22.24
(45%)
23.79
(47%)
36.13
(49%)
67.94
(16%)
[1]
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06293620 0.3 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 17.66
Confidence Interval (2-Sided) 90%
8.44 to 36.95
Estimation Comments PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06293620 1.0 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 32.73
Confidence Interval (2-Sided) 90%
21.64 to 49.51
Estimation Comments PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06293620 3.0 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 35.02
Confidence Interval (2-Sided) 90%
23.60 to 51.95
Estimation Comments PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06293620 6.0 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 53.18
Confidence Interval (2-Sided) 90%
36.36 to 77.78
Estimation Comments PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
6.Secondary Outcome
Title Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Hide Description Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 5 5 6 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*hr/mL
128.3
(54%)
1619
(46%)
5945
(53%)
18080
(58%)
6509
(13%)
7.Secondary Outcome
Title Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
Hide Description AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 5 5 6 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*hr/mL/mg
4.779
(58%)
21.01
(44%)
22.47
(47%)
33.59
(50%)
65.26
(18%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06293620 0.3 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 7.32
Confidence Interval (2-Sided) 90%
4.70 to 11.40
Estimation Comments PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06293620 1.0 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 32.19
Confidence Interval (2-Sided) 90%
20.67 to 50.12
Estimation Comments PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06293620 3.0 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 34.43
Confidence Interval (2-Sided) 90%
22.57 to 52.52
Estimation Comments PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06293620 6.0 mg/kg SC (SAD Cohorts), PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Test relative to Reference
Estimated Value 51.47
Confidence Interval (2-Sided) 90%
34.26 to 77.31
Estimation Comments PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
8.Secondary Outcome
Title Clearance (CL) of PF-06293620 (SAD Cohorts)
Hide Description Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/hr
14.72
(16%)
9.Secondary Outcome
Title Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
Hide Description Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 1 5 6 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/hr
83.20 [1] 
(NA%)
44.93
(45%)
42.05
(47%)
27.67
(49%)
[1]
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
10.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
Hide Description Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 6 5 6 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
0.3907
(58%)
2.896
(48%)
7.222
(52%)
22.30
(62%)
27.64
(20%)
11.Secondary Outcome
Title Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
Hide Description Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 6 5 6 7 6
Median (Full Range)
Unit of Measure: hours
168
(71.9 to 336)
168
(48.0 to 504)
252
(95.9 to 504)
168
(96.0 to 504)
1.00
(1.00 to 2.00)
12.Secondary Outcome
Title Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
Hide Description Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
7.095
(1.00% to 2.00%)
13.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
Hide Description Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 1 5 6 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
21.10 [1] 
(NA%)
16.25
(43%)
20.63
(44%)
18.17
(48%)
[1]
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
14.Secondary Outcome
Title Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
Hide Description Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Time Frame Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Hide Arm/Group Description:
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 1 5 6 7 6
Mean (Standard Deviation)
Unit of Measure: days
7.33 [1]   (NA) 10.95  (3.74) 14.66  (4.21) 19.23  (3.45) 14.37  (3.13)
[1]
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
15.Secondary Outcome
Title Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Hide Description Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 8 16 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*hr/mL
Day 1 Number Analyzed 8 participants 16 participants 8 participants
609.6
(137%)
802.5
(79%)
2752
(73%)
Day 57 Number Analyzed 7 participants 14 participants 7 participants
1309
(60%)
2991
(57%)
6121
(48%)
16.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Hide Description [Not Specified]
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 8 16 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
Day 1 Number Analyzed 8 participants 16 participants 8 participants
1.526
(139%)
1.706
(72%)
5.184
(73%)
Day 57 Number Analyzed 8 participants 14 participants 7 participants
1.989
(183%)
6.012
(65%)
11.74
(56%)
17.Secondary Outcome
Title Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Hide Description Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 8 16 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
Day 1 Number Analyzed 8 participants 16 participants 8 participants
0.9067
(137%)
1.194
(79%)
4.096
(73%)
Day 57 Number Analyzed 7 participants 14 participants 7 participants
1.948
(60%)
4.449
(57%)
9.102
(48%)
18.Secondary Outcome
Title Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Hide Description [Not Specified]
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 7 14 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
0.7555
(94%)
1.979
(72%)
5.456
(48%)
19.Secondary Outcome
Title Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Hide Description Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 8 16 8
Median (Full Range)
Unit of Measure: hours
Day 1 Number Analyzed 8 participants 16 participants 8 participants
240
(144 to 338)
252
(48.0 to 338)
360
(144 to 648)
Day 57 Number Analyzed 8 participants 14 participants 7 participants
168
(47.8 to 192)
144
(47.5 to 648)
120
(48.0 to 504)
20.Secondary Outcome
Title Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Hide Description Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 7 14 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/hr
38.19
(60%)
25.07
(57%)
24.53
(47%)
21.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Hide Description Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 7 14 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters
13.43
(38%)
10.45
(52%)
12.09
(40%)
22.Secondary Outcome
Title Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Hide Description Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 7 14 7
Mean (Standard Deviation)
Unit of Measure: days
10.37  (2.22) 12.72  (4.21) 14.50  (2.81)
23.Secondary Outcome
Title Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
Hide Description Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 7 14 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.833
(64%)
3.446
(36%)
2.148
(30%)
24.Secondary Outcome
Title Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
Hide Description Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).
Time Frame Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description:
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 8 14 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.302
(114%)
3.257
(42%)
2.188
(22%)
Time Frame Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
Adverse Event Reporting Description MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
 
Arm/Group Title Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Hide Arm/Group Description One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
All-Cause Mortality
Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/9 (0.00%)   0/2 (0.00%)   0/6 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/16 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/6 (0.00%)   0/9 (0.00%)   0/2 (0.00%)   0/6 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   1/16 (6.25%)   2/8 (25.00%) 
Cardiac disorders                       
Angina unstable * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Coronary artery disease * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Hepatobiliary disorders                       
Cholelithiasis * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications                       
Joint injury * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo SC (SAD Cohorts) PF-06293620 0.3 mg/kg SC (SAD Cohorts) PF-06293620 1.0 mg/kg SC (SAD Cohorts) PF-06293620 3.0 mg/kg SC (SAD Cohorts) PF-06293620 6.0 mg/kg SC (SAD Cohorts) Placebo IV (SAD Cohorts) PF-06293620 1.0 mg/kg IV (SAD Cohorts) Placebo SC (MAD Cohorts) PF-06293620 50 mg SC (MAD Cohorts) PF-06293620 75 mg SC (MAD Cohorts) PF-06293620 150 mg SC (MAD Cohorts)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   3/6 (50.00%)   3/6 (50.00%)   5/6 (83.33%)   5/9 (55.56%)   0/2 (0.00%)   3/6 (50.00%)   4/8 (50.00%)   4/8 (50.00%)   11/16 (68.75%)   7/8 (87.50%) 
Blood and lymphatic system disorders                       
Iron deficiency anaemia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  3/8 (37.50%) 
Gastrointestinal disorders                       
Abdominal distension * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Abdominal pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Abdominal pain lower * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Abdominal pain upper * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Constipation * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  1/8 (12.50%) 
Diarrhoea * 1  2/9 (22.22%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/16 (12.50%)  0/8 (0.00%) 
Dry mouth * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Flatulence * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Gastrooesophageal reflux disease * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Toothache * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Vomiting * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Nausea * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
General disorders                       
Asthenia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Hunger * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Infusion site extravasation * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Infusion site hemorrhage * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Injection site pruritus * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Malaise * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Hepatobiliary disorders                       
Biliary colic * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Cholelithiasis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Infections and infestations                       
Body tinea * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Bronchitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Cellulitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/9 (11.11%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Infective glossitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Influenza * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Pharyngitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Upper respiratory tract infection * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Viral pharyngitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Sinusitis * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Viral infection * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Viral upper respiratory tract infection * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Nasopharyngitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications                       
Fall * 1  3/9 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Ligament rupture * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Skin abrasion * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Investigations                       
Blood creatine phosphokinase increased * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Blood pressure increased * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  1/8 (12.50%) 
Haemoglobin decreased * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Liver function test increased * 1  1/9 (11.11%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/9 (22.22%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  5/8 (62.50%) 
Metabolism and nutrition disorders                       
Gout * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Decreased appetite * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Arthralgia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Back pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Musculoskeletal pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  1/8 (12.50%) 
Pain in extremity * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Soft tissue swelling * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Muscle spasms * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Nervous system disorders                       
Tension headache * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Dizziness * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Somnolence * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Psychiatric disorders                       
Insomnia * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Reproductive system and breast disorders                       
Prostatitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/16 (6.25%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders                       
Cough * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Pleuritic pain * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders                       
Dermatitis contact * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Diabetic dermopathy * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Ecchymosis * 1  2/9 (22.22%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Skin irritation * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/16 (0.00%)  0/8 (0.00%) 
Vascular disorders                       
Hypertension * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
Originally planned 250 mg cohort was not enrolled in MAD part, because 150 mg cohort already demonstrated optimal glucose-lowering effect. Protocol-specified TBD (to be determined) dose level was 50 mg as well as expansion of the 75 mg cohort.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02211261    
Other Study ID Numbers: B3501001
First Submitted: August 6, 2014
First Posted: August 7, 2014
Results First Submitted: January 22, 2018
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018