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A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH

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ClinicalTrials.gov Identifier: NCT02264639
Recruitment Status : Completed
First Posted : October 15, 2014
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Paroxysmal Nocturnal Hemoglobinuria (PNH)
Intervention Drug: Pegcetacoplan
Enrollment 9
Recruitment Details Paroxysmal nocturnal hemoglobinuria (PNH) subjects who were still anemic during treatment with eculizumab (Soliris®) were enrolled in this Phase 1, open-label, single- and multiple-ascending dose study to receive treatment with pegcetacoplan (APL-2) as an add-on to standard of care treatment. The study was conducted at 7 sites in the United States.
Pre-assignment Details Subjects could participate in more than 1 cohort. Overall, 9 unique subjects were evaluated in 4 cohorts, with some subjects participating in >1 cohort. Single-dose phase: 4 unique subjects evaluated (2 each in Cohorts 1 and 2). Multiple-dose phase: 8 unique subjects evaluated, comprising 3 subjects who also participated in single-dose phase (1 in Cohort 1; 2 in Cohort 2) plus a further 5 unique subjects. Each cohort included a 30-day screening phase prior to treatment with pegcetacoplan.
Arm/Group Title Cohort 1 Single- and Multiple-dose Phase Cohort 2 Single- and Multiple-dose Phase Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase Cohorts 3 and 4 Multiple-dose Phase Cohort 4 Multiple-dose Phase
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Cohort 1 single-dose phase: Subjects received a single subcutaneous (SC) dose of 25 milligrams (mg) pegcetacoplan on Day 1.

Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).

Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.

Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).

Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.

Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).

Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).

Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:

  • Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
  • Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
  • Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
  • Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.

After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).

Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:

  • Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
  • Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
  • Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
  • Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.

After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:

  • Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
  • Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
  • Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
  • Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.

After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Period Title: Overall Study
Started 2 [1] 1 [2] 1 [3] 1 [4] 4 [5]
Completed [6] 0 1 0 1 3
Not Completed 2 0 1 0 1
Reason Not Completed
Death (after completing single-dose phase)             1             0             0             0             0
Withdrawal by subject (during multiple-dose phase)             1             0             0             0             0
Pregnancy (during multiple-dose phase)             0             0             1             0             0
Major Intercurrent Illness (during multiple-dose phase)             0             0             0             0             1
[1]
Subjects in this arm participated in Cohort 1 only.
[2]
Subject in this arm participated in Cohort 2 only.
[3]
Subject in this arm participated in Cohorts 2, 3 and 4.
[4]
Subject in this arm participated in Cohorts 3 and 4; single-dose phase was not applicable.
[5]
Subjects in this arm participated in Cohort 4 only; single-dose phase was not applicable.
[6]
Completed the study (with reference to the last cohort in which a subject participated).
Arm/Group Title Cohort 1 Single- and Multiple-dose Phase Cohort 2 Single- and Multiple-dose Phase Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase Cohorts 3 and 4 Multiple-dose Phase Cohort 4 Multiple-dose Phase Total
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Cohort 1 single-dose phase: Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.

Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).

Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.

Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).

Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.

Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).

Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).

Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:

  • Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
  • Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
  • Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
  • Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.

After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).

Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:

  • Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
  • Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
  • Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
  • Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.

After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:

  • Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
  • Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
  • Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
  • Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.

After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Total of all reporting groups
Overall Number of Baseline Participants 2 1 1 1 4 9
Hide Baseline Analysis Population Description
The safety population included all enrolled subjects who received at least 1 dose of study drug. Total unique participants = 9. Subjects could participate in more than 1 cohort. 1 subject participated in Cohorts 2, 3 and 4, and 1 subject participated in Cohorts 3 and 4.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
1
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
8
  88.9%
>=65 years
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 4 participants 9 participants
Female 2 0 1 1 4 8
Male 0 1 0 0 0 1
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 4 participants 9 participants
Hispanic or Latino 0 0 0 1 0 1
Not Hispanic or Latino 2 1 1 0 4 8
Unknown or Not Reported 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 4 participants 9 participants
American Indian or Alaska Native 0 0 0 0 0 0
Asian 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 0 0 0 0 1 1
White 2 1 1 1 3 8
More than one race 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 1 participants 1 participants 4 participants 9 participants
2 1 1 1 4 9
1.Primary Outcome
Title Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
Hide Description TEAEs were defined as AEs that developed or worsened after first dose of study drug (Day 1), and up to 30 days after last dose of study drug. The Investigator assessed AEs for severity and relatedness to study drug. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Time Frame From single dose of study drug (Day 1) up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled subjects who received at least 1 dose of study drug.
Arm/Group Title Cohort 1 Single-dose Phase Cohort 2 Single-dose Phase
Hide Arm/Group Description:
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Overall Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
1
  50.0%
2
 100.0%
TEAE at least possibly related to study drug
0
   0.0%
1
  50.0%
Serious TEAE
0
   0.0%
0
   0.0%
TEAE leading to study drug discontinuation
0
   0.0%
0
   0.0%
TEAE leading to death
0
   0.0%
0
   0.0%
Maximum severity of all TEAEs: mild
0
   0.0%
1
  50.0%
Maximum severity of all TEAEs: moderate
1
  50.0%
1
  50.0%
Maximum severity of all TEAEs: severe
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Hide Description TEAEs were defined as AEs that developed or worsened after first dose of study drug (Day 1), and up to 30 days after last dose of study drug. The Investigator assessed AEs for severity and relatedness to study drug. AEs were graded according to CTCAE, v4.03 based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Time Frame From first dose of study drug up to 30 days after last dose of study drug (Cohorts 1-3: up to 58 days; Cohort 4: up to 759 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled subjects who received at least 1 dose of study drug.
Arm/Group Title Cohort 1 Multiple-dose Phase Cohort 2 Multiple-dose Phase Cohort 3 Multiple-dose Phase Cohort 4 Multiple-dose Phase
Hide Arm/Group Description:
Subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
Subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).

Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).

After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Overall Number of Participants Analyzed 1 2 2 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
1
 100.0%
2
 100.0%
1
  50.0%
6
 100.0%
TEAE at least possibly related to study drug
0
   0.0%
1
  50.0%
1
  50.0%
4
  66.7%
Serious TEAE
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
TEAE leading to study drug discontinuation
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
TEAE leading to death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Maximum severity of all TEAEs: mild
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
Maximum severity of all TEAEs: moderate
0
   0.0%
2
 100.0%
0
   0.0%
2
  33.3%
Maximum severity of all TEAEs: severe
1
 100.0%
0
   0.0%
0
   0.0%
4
  66.7%
Maximum severity of all TEAEs: life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Area Under the Curve (AUC) From Time 0 to the Last Measurable Concentration (AUC0-t) Over the Multiple Dosing Phase for Cohort 4
Hide Description Assessment of AUC0-t of pegcetacoplan over the multiple dosing phase, estimated using a non-compartmental approach and calculated by the linear-log trapezoidal method. Pegcetacoplan pharmacokinetic (PK) parameters were summarized for Cohort 4 only.
Time Frame Blood samples for PK assessment were collected pre-dose and 4 hours post dose on Day 1 and pre-dose (trough) on Day 2 and up to Day 785.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population was defined as all subjects in the safety population who had at least 1 PK sample drawn with a measurable serum concentration. Results were reported for Cohort 4 only. Due to the small sample size in Cohorts 1 through 3, summaries for continuous data using descriptive statistics were not performed.
Arm/Group Title Cohort 4 Multiple-dose Phase
Hide Arm/Group Description:

Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).

After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: micrograms*hour/milliliter (μg*hour/mL)
6,500,000  (3,990,000)
4.Primary Outcome
Title Maximum Pre-dose Serum Concentration (Ctrough,Max) Over the Multiple Dosing Phase for Cohort 4
Hide Description Assessment of Ctrough,max of pegcetacoplan over the multiple dosing phase, estimated using a non-compartmental approach. Pegcetacoplan PK parameters were summarized for Cohort 4 only. Ctrough,max was calculated for both 270 mg/day and 360 mg/day where subjects received both doses. Note: 1 subject in Cohort 4 who was receiving 360 mg/day was granted Sponsor and institutional review board approval to increase the dose further to the equivalent of 440 mg/day and Ctrough,max is also reported for this dose.
Time Frame Blood samples for PK assessment were collected pre-dose and 4 hours post dose on Day 1 and pre-dose (trough) on Day 2 and up to Day 785.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population was defined as all subjects in the safety population who had at least 1 PK sample drawn with a measurable serum concentration. Results were reported for Cohort 4 only. Due to the small sample size in Cohorts 1 through 3, summaries for continuous data using descriptive statistics were not performed.
Arm/Group Title Cohort 4 Multiple-dose Phase
Hide Arm/Group Description:

Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).

After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: μg/mL
270 mg Dose Number Analyzed 6 participants
627  (207)
360 mg Dose Number Analyzed 4 participants
543  (192)
440 mg Dose Number Analyzed 1 participants
624 [1]   (NA)
[1]
No standard deviation is presented since mean value is derived from a single subject.
Time Frame TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
Adverse Event Reporting Description The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
 
Arm/Group Title Cohort 1 Single-dose Phase Cohort 2 Single-dose Phase Cohort 1 Multiple-dose Phase Cohort 2 Multiple-dose Phase Cohort 3 Multiple-dose Phase Cohort 4 Multiple-dose Phase
Hide Arm/Group Description Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1. Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1. Subjects received pegcetacoplan 5 mg/day as SC dose for 28 days (from Day 29 to Day 56). Subjects received pegcetacoplan 30 mg/day as SC dose for 28 days (from Day 29 to Day 56). Subjects received pegcetacoplan 180 mg/day as SC dose for 28 days (from Day 1 to Day 28).

Subjects received pegcetacoplan 270 mg/day as SC dose for up to 729 days (from Day 1 up to Day 729).

After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.

All-Cause Mortality
Cohort 1 Single-dose Phase Cohort 2 Single-dose Phase Cohort 1 Multiple-dose Phase Cohort 2 Multiple-dose Phase Cohort 3 Multiple-dose Phase Cohort 4 Multiple-dose Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)      0/2 (0.00%)      0/1 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Cohort 1 Single-dose Phase Cohort 2 Single-dose Phase Cohort 1 Multiple-dose Phase Cohort 2 Multiple-dose Phase Cohort 3 Multiple-dose Phase Cohort 4 Multiple-dose Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)      0/1 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      2/6 (33.33%)    
Blood and lymphatic system disorders             
Anaemia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders             
Lower gastrointestinal haemorrhage  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Pancreatitis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Hepatobiliary disorders             
Portal vein thrombosis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations             
Sepsis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Investigations             
Alanine aminotransferase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Aspartate aminotransferase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Single-dose Phase Cohort 2 Single-dose Phase Cohort 1 Multiple-dose Phase Cohort 2 Multiple-dose Phase Cohort 3 Multiple-dose Phase Cohort 4 Multiple-dose Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      2/2 (100.00%)      1/1 (100.00%)      2/2 (100.00%)      1/2 (50.00%)      6/6 (100.00%)    
Ear and labyrinth disorders             
Hyperacusis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Eye disorders             
Eye pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Vision blurred  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  2
Eye irritation  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Eye pruritus  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Photophobia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders             
Nausea  1  1/2 (50.00%)  2 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/6 (16.67%)  4
Diarrhoea  1  1/2 (50.00%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/6 (16.67%)  5
Abdominal pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/6 (50.00%)  4
Abdominal discomfort  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Abdominal pain upper  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Dyspepsia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/6 (0.00%)  0
Lip blister  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Rectal hemorrhage  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
General disorders             
Fatigue  1  0/2 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  5
Oedema peripheral  1  0/2 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/6 (16.67%)  1
Injection-site bruising  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 2/2 (100.00%)  4 1/2 (50.00%)  1 4/6 (66.67%)  145
Injection-site induration  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  43
Injection-site erythema  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 3/6 (50.00%)  19
Injection-site pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 4/6 (66.67%)  13
Injection-site swelling  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  9
Pyrexia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/6 (50.00%)  8
Injection-site pruritus  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  7
Infusion-site bruising  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Injection-site haemorrhage  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Asthenia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Chills  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Induration  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Influenza like illness  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Injection-site discomfort  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Injection-site oedema  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Injection-site warmth  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Malaise  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Non-cardiac chest pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
Pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Hepatobiliary disorders             
Hyperbilirubinaemia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Immune system disorders             
Seasonal allergy  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Infections and infestations             
Upper respiratory tract infection  1  1/2 (50.00%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  2
Urinary tract infection  1  1/2 (50.00%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  3
Ear infection  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Influenza  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  2
Injury, poisoning and procedural complications             
Contusion  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  4
Excoriation  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Fall  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Procedural pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Investigations             
Serum ferritin increased  1  1/2 (50.00%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
Alanine aminotransferase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/6 (50.00%)  4
Aspartate aminotransferase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  3
Activated partial thromboplastin time prolonged  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  2
Blood alkaline phosphatase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Blood glucose increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Blood lactate dehydrogenase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Body temperature increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Electrocardiogram abnormal  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Gamma-glutamyltransferase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Lipase increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Neutrophil count decreased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Transaminases increased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Vitamin B12 decreased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
White blood cell count decreased  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders             
Decreased appetite  1  0/2 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Hypokalaemia  1  1/2 (50.00%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Hypoalbuminaemia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Hypocalcaemia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Hypomagnesaemia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders             
Myalgia  1  0/2 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 2/6 (33.33%)  2
Pain in extremity  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 3/6 (50.00%)  7
Back pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/6 (50.00%)  7
Muscle spasms  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  2 2/6 (33.33%)  2
Musculoskeletal stiffness  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 1/6 (16.67%)  1
Musculoskeletal pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Pain in jaw  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders             
Memory impairment  1  0/2 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
Headache  1  0/2 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 5/6 (83.33%)  11
Burning sensation  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Dizziness  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/6 (16.67%)  1
Hypersomnia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 1/2 (50.00%)  1 0/6 (0.00%)  0
Dysaesthesia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
Lethargy  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Diplopia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  2
Psychiatric disorders             
Anxiety  1  0/2 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 1/2 (50.00%)  1 0/2 (0.00%)  0 0/6 (0.00%)  0
Depression  1  0/2 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders             
Nephrolithiasis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Pollakiuria  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/6 (0.00%)  0
Polyuria  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Urine odour abnormal  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal pain  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/6 (50.00%)  3
Nasal congestion  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  2
Dyspnoea  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/6 (0.00%)  0
Productive cough  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Rhinorrhoea  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Sneezing  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders             
Night sweats  1  0/2 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/6 (0.00%)  0
Ecchymosis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  12
Pruritus  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 2/6 (33.33%)  9
Petechiae  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  4
Rash  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  3
Erythema  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/6 (33.33%)  2
Alopecia  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Decubitus ulcer  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Dry skin  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Generalised erythema  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Onychoclasis  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/6 (0.00%)  0
Rash macular  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Urticaria  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders             
Hot flush  1  0/2 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
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Name/Title: Apellis Clinical Trial Information Line
Organization: Apellis Pharmaceuticals, Inc.
Phone: 1-833-284-6361
EMail: clinicaltrials@apellis.com
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02264639    
Other Study ID Numbers: APL-CP0514
First Submitted: October 8, 2014
First Posted: October 15, 2014
Results First Submitted: July 31, 2020
Results First Posted: January 8, 2021
Last Update Posted: January 8, 2021