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Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00877032
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Age-Related Maculopathy
Age-Related Maculopathies
Eye Diseases
Retinal Degeneration
Macular Degeneration
Interventions Biological: RN6G
Biological: Placebo
Enrollment 57
Recruitment Details  
Pre-assignment Details From a given cohort, no more than 3 participants received treatment on Day 1, the remaining participants in the respective cohort received treatment at least 24 hours thereafter. All the remaining participants were treated on same day, if required, as per site scheduling.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Period Title: Overall Study
Started 6 6 6 7 6 6 20
Treated 6 6 6 6 6 6 18
Completed 6 6 6 6 6 6 18
Not Completed 0 0 0 1 0 0 2
Reason Not Completed
Did not meet entrance criteria             0             0             0             1             0             0             2
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo Total
Hide Arm/Group Description Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of placebo matched to RN6G on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 18 54
Hide Baseline Analysis Population Description
Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 54 participants
68.2  (11.1) 70.2  (9.9) 65.5  (10.4) 69.2  (3.7) 67.8  (7.5) 65.0  (6.5) 67.4  (8.2) 67.6  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 54 participants
Female
4
  66.7%
2
  33.3%
5
  83.3%
2
  33.3%
5
  83.3%
4
  66.7%
14
  77.8%
36
  66.7%
Male
2
  33.3%
4
  66.7%
1
  16.7%
4
  66.7%
1
  16.7%
2
  33.3%
4
  22.2%
18
  33.3%
1.Primary Outcome
Title Incidence and Severity of Ocular Adverse Events (AEs)
Hide Description AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.
Time Frame Baseline up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 18
Measure Type: Number
Unit of Measure: participants
Ocular AEs 1 3 2 1 4 3 6
Mild ocular AEs: right eye 1 1 1 0 1 0 2
Mild ocular AEs: left eye 1 2 1 0 1 2 2
Mild ocular AEs: both eyes 0 1 1 1 2 1 3
Moderate ocular AEs: right eye 1 1 1 0 1 0 1
Moderate ocular AEs: left eye 1 0 0 0 2 0 1
Moderate ocular AEs: both eyes 0 0 0 0 0 0 0
Severe ocular AEs: right eye 0 0 0 0 0 0 0
Severe ocular AEs: left eye 0 0 0 0 0 0 0
Severe ocular AEs: both eyes 0 0 0 0 0 0 0
2.Primary Outcome
Title Incidence and Severity of Systemic Adverse Events (AEs)
Hide Description AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.
Time Frame Baseline up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 18
Measure Type: Number
Unit of Measure: participants
Systemic AEs 4 5 5 4 6 6 15
Mild systemic AEs 4 5 5 2 6 5 15
Moderate systemic AEs 1 2 2 2 3 2 7
Severe systemic AEs 0 0 0 0 0 0 0
3.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G
Hide Description AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 5 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: microgram*hour/milliliter (mcg*hr/mL)
1003  (399) 4516  (627) 19591  (3657) 76987  (18255) 163049  (57995) 486191  (64822)
4.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G
Hide Description AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mcg*hr/mL
836  (326) 3990  (593) 17878  (3395) 72792  (15929) 155377  (52319) 472239  (59181)
5.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of RN6G
Hide Description Participants who received RN6G were reported.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mcg/mL
4.70  (0.87) 23.1  (2.9) 75.2  (9.3) 286  (58) 435  (87) 1245  (142)
6.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G
Hide Description Participants who received RN6G were reported.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hours
2.1
(2.0 to 3.3)
2.1
(2.0 to 3.1)
2.0
(2.0 to 6.2)
4.5
(3.0 to 14.2)
2.5
(2.1 to 10.0)
2.1
(2.0 to 6.0)
7.Secondary Outcome
Title Volume of Distribution (Vd) of RN6G
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 5 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/kilogram (mL/kg)
384  (86.8) 555  (180) 336  (74.8) 230  (39.5) 198  (57.1) 98.0  (12.1)
8.Secondary Outcome
Title Clearance (CL) of RN6G
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 5 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/hr/kg
0.336  (0.117) 0.225  (0.0287) 0.158  (0.031) 0.137  (0.037) 0.134  (0.040) 0.0835  (0.0115)
9.Secondary Outcome
Title Mean Residence Time (MRT) of RN6G
Hide Description MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 5 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: days
36.2  (19.7) 57.3  (16.8) 51.5  (5.8) 37.7  (8.3) 41.9  (10.0) 38.0  (6.8)
10.Secondary Outcome
Title Plasma Terminal Half-life (t1/2) of RN6G
Hide Description Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Overall Number of Participants Analyzed 5 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: days
37.5  (20.1) 71.5  (20.5) 61.4  (5.8) 50.1  (9.4) 43.3  (6.7) 34.2  (5.1)
11.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)
Hide Description [Not Specified]
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 18
Mean (Standard Deviation)
Unit of Measure: picogram/milliliter (pg/mL)
3607  (1517) 10318  (3312) 21267  (2836) 59000  (14599) 70967  (10265) 75700  (11773) 533  (177)
12.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)
Hide Description [Not Specified]
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 18
Median (Full Range)
Unit of Measure: hours
14.3
(6.3 to 27.0)
26.0
(14.1 to 26.0)
26.1
(23.9 to 149)
160
(148 to 461)
317
(169 to 651)
402
(270 to 1330)
14.3
(1.0 to 4012)
13.Secondary Outcome
Title Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)
Hide Description AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.
Time Frame Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 18
Mean (Standard Deviation)
Unit of Measure: nanogram*hr/mL (ng*hr/mL)
2512  (752) 4512  (1780) 12041  (2553) 46852  (12562) 85441  (22829) 113547  (19280) 1572  (392)
14.Secondary Outcome
Title Number of Participants With Anti-Drug Anti-body
Hide Description Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.
Time Frame Baseline up to Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description:
Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
Single intravenous infusion dose of placebo matched to RN6G on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 18
Measure Type: Number
Unit of Measure: participants
2 1 0 2 1 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Hide Arm/Group Description Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. Single intravenous infusion dose of placebo matched to RN6G on Day 1.
All-Cause Mortality
RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/18 (0.00%) 
Nervous system disorders               
Carotid artery stenosis * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RN6G 0.3 mg/kg RN6G 1 mg/kg RN6G 3 mg/kg RN6G 10 mg/kg RN6G 20 mg/kg RN6G 40 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   5/6 (83.33%)   5/6 (83.33%)   4/6 (66.67%)   6/6 (100.00%)   6/6 (100.00%)   15/18 (83.33%) 
Cardiac disorders               
Atrial fibrillation * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Atrioventricular block first degree * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Sinus arrhythmia * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Supraventricular extrasystoles * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders               
Tinnitus * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Vertigo * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Eye disorders               
Blepharitis * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Cataract * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Cataract cortical * 1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/18 (16.67%) 
Cataract nuclear * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Cataract subcapsular * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Conjunctival hyperaemia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Iritis * 1  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/18 (5.56%) 
Lacrimation increased * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Ocular icterus * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Pupillary disorder * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Retinal haemorrhage * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Retinal pigment epitheliopathy * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Visual acuity reduced * 1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Visual impairment * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Vitreous detachment * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders               
Abdominal pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Colonic polyp * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Diarrhoea * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Diverticulum * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Nausea * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Vomiting * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
General disorders               
Fatigue * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Infusion site haematoma * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Injection site pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Pyrexia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Sensation of foreign body * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/18 (0.00%) 
Swelling * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Vessel puncture site haemorrhage * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Infections and infestations               
Bronchitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Cystitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Influenza * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Nasopharyngitis * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Rash pustular * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Sinusitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Upper respiratory tract infection * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Urinary tract infection * 1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  0/18 (0.00%) 
Vulvovaginal mycotic infection * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications               
Back injury * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Contusion * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Excoriation * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Femur fracture * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Incision site pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Joint sprain * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Limb injury * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Investigations               
Aspartate aminotransferase increased * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Blood creatine phosphokinase increased * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Blood glucose increased * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Blood iron decreased * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Blood phosphorus increased * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Blood pressure diastolic decreased * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Blood pressure increased * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Blood triglycerides increased * 1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Body temperature increased * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Visual acuity tests abnormal * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/18 (5.56%) 
Weight decreased * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Metabolism and nutrition disorders               
Hypercholesterolaemia * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Arthritis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Back pain * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Costochondritis * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Muscle spasms * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Musculoskeletal pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Neck pain * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Pain in extremity * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Cyst * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Nervous system disorders               
Cognitive disorder * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Dizziness * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Headache * 1  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  4/6 (66.67%)  2/6 (33.33%)  3/18 (16.67%) 
Migraine with aura * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Paraesthesia oral * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Presyncope * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Sensory disturbance * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Psychiatric disorders               
Abnormal dreams * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
Anxiety * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Insomnia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Renal and urinary disorders               
Polyuria * 1  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Reproductive system and breast disorders               
Benign prostatic hyperplasia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Oropharyngeal pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Wheezing * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders               
Dermatitis contact * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Dyshidrosis * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Hyperhidrosis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Rash * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Skin laceration * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Vascular disorders               
Contusion * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Poor peripheral circulation * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Results for pharmacodynamic parameters [Cmax, Tmax and AUC (0-65d) of A beta(1-X)], are presented as absolute values at specified time points and not as change from baseline as planned.
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00877032     History of Changes
Other Study ID Numbers: B1181001
First Submitted: April 6, 2009
First Posted: April 7, 2009
Results First Submitted: March 20, 2015
Results First Posted: March 31, 2015
Last Update Posted: March 31, 2015