Trial Outcomes & Findings for A Study of a Single Dose of ALXN1210 in Healthy Participants (NCT NCT05288660)
NCT ID: NCT05288660
Last Updated: 2023-05-09
Results Overview
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Baseline up to Day 150
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
Cohort 1: ALXN1210 200 mg
Participants received single dose of ALXN1210 200 milligrams (mg), via intravenous (IV) infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
6
|
4
|
|
Overall Study
COMPLETED
|
4
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of a Single Dose of ALXN1210 in Healthy Participants
Baseline characteristics by cohort
| Measure |
ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 9.42 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 8.33 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 8.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 150Population: The safety population included the group of participants who received any dose of the study drug (ALXN1210 or placebo).
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The pharmacokinetic (PK) population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of Cmax by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of ALXN1210
|
78.8 microgram/milliliter (µg/mL)
Standard Deviation 8.02
|
141 microgram/milliliter (µg/mL)
Standard Deviation 23.9
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of Tmax by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Time To Maximum Observed Serum Concentration (Tmax) of ALXN1210
|
2.44 hours
Interval 0.8 to 4.248
|
0.657 hours
Interval 0.594 to 1.161
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of AUC0-t by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of ALXN1210
|
45400 microgram*hour/milliliter (µg*hr/mL)
Standard Deviation 5240
|
78900 microgram*hour/milliliter (µg*hr/mL)
Standard Deviation 16300
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of AUCinf by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of ALXN1210
|
47600 µg*hr/mL
Standard Deviation 6220
|
81900 µg*hr/mL
Standard Deviation 17800
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of λz by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of Serum ALXN1210
|
0.000900 1/hour
Standard Deviation 0.000146
|
0.000943 1/hour
Standard Deviation 0.0000934
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of t½ by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Terminal Elimination Half-life (t½) of Serum ALXN1210
|
32.7 days
Standard Deviation 5.18
|
30.9 days
Standard Deviation 3.20
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of CL by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Total Clearance (CL) of ALXN1210
|
4.26 milliliter/hour
Standard Deviation 0.620
|
5.06 milliliter/hour
Standard Deviation 0.990
|
—
|
SECONDARY outcome
Timeframe: Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150Population: The PK population included all participants who received ALXN1210 and who had sufficient serum ALXN1210 concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of Vd by noncompartmental analyses using Pharsight Knowledgebase Server 4.0.2 and Phoenix WinNonlin 5.3.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Volume of Distribution (Vd) of ALXN1210
|
4760 milliliters
Standard Deviation 426
|
5340 milliliters
Standard Deviation 727
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: The pharmacodynamic (PD) population consisted of all participants who had sufficient pre and post dose PD assessments (C5 concentration data, chicken red blood cell \[cRBC\] hemolysis data, classical complement pathway \[CCP\], complement alternative pathway \[CAP\], or terminal complement complex \[C5b-9\]) to enable the evaluation of the PD effects.
Blood samples were collected for analysis of free C5 concentrations.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percent Change From Baseline in Free Complement Component 5 (C5)
|
4.76 percent change
Standard Deviation 5.52
|
19.88 percent change
Standard Deviation 12.99
|
24.46 percent change
Standard Deviation 31.63
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: The PD population consisted of all participants who had sufficient pre and post dose PD assessments (C5 concentration data, cRBC hemolysis data, CCP, CAP, or C5b-9) to enable the evaluation of the PD effects.
Blood samples were collected for analysis of total C5 concentrations.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Complement C5
|
31.02 percent change
Standard Deviation 8.34
|
23.39 percent change
Standard Deviation 10.46
|
15.33 percent change
Standard Deviation 17.86
|
SECONDARY outcome
Timeframe: Baseline, Day 8Population: The PD population consisted of all participants who had sufficient pre and post dose PD assessments (C5 concentration data, cRBC hemolysis data, CCP, CAP, or C5b-9) to enable the evaluation of the PD effects.
Blood samples were collected for analysis of C5b-9 concentrations.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percent Change From Baseline in Complement C5b-9
|
-28.22 percent change
Standard Deviation 19.11
|
-40.73 percent change
Standard Deviation 10.92
|
34.68 percent change
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: The PD population consisted of all participants who had sufficient pre and post dose PD assessments (C5 concentration data, cRBC hemolysis data, CCP, CAP, or C5b-9) to enable the evaluation of the PD effects.
Blood samples were collected for analysis of cRBC hemolysis.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percent Change From Baseline in Chicken Red Blood Cell Hemolysis
|
9.86 percent change
Standard Deviation 7.57
|
15.30 percent change
Standard Deviation 29.35
|
-4.68 percent change
Standard Deviation 4.76
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: The PD population consisted of all participants who had sufficient pre and post dose PD assessments (C5 concentration data, cRBC hemolysis data, CCP, CAP, or C5b-9) to enable the evaluation of the PD effects.
Blood samples were collected for analysis of CCP.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percent Change From Baseline In Complement Classical Pathway (CCP) Activity
|
-13.16 percent change
Standard Deviation 13.65
|
5.34 percent change
Standard Deviation 6.05
|
-1.81 percent change
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: The PD population consisted of all participants who had sufficient pre and post dose PD assessments (C5 concentration data, cRBC hemolysis data, CCP, CAP, or C5b-9) to enable the evaluation of the PD effects.
Blood samples were collected for analysis of CAP.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 Participants
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percent Change From Baseline In Complement Alternative Pathway (CAP) Activity
|
-23.61 percent change
Standard Deviation 19.91
|
-24.66 percent change
Standard Deviation 18.48
|
-22.08 percent change
Standard Deviation 13.18
|
SECONDARY outcome
Timeframe: Baseline up to Day 150Population: The immunogenicity analysis population consisted of all participants who had pre-dose and at least one post-dose human anti-human antibodies (HAHA) sample collected. The outcome measure was planned to be analyzed for Cohort 1: ALXN1210 200 mg and Cohort 2: ALXN1210 400 mg arms only.
Blood samples were collected to evaluate antibody response through development of ADAs.
Outcome measures
| Measure |
Cohort 1: ALXN1210 200 mg
n=4 Participants
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Cohort 2: ALXN1210 400 mg
n=6 Participants
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
Adverse Events
ALXN1210 200 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ALXN1210 400 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALXN1210 200 mg
n=4 participants at risk
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
ALXN1210 400 mg
n=6 participants at risk
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 participants at risk
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
Other adverse events
| Measure |
ALXN1210 200 mg
n=4 participants at risk
Participants received single dose of ALXN1210 200 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
ALXN1210 400 mg
n=6 participants at risk
Participants received single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed up to Day 150.
|
Placebo
n=4 participants at risk
Participants received placebo matched to ALXN1210 via IV infusion on Day 1. Participants were followed up to Day 150.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
50.0%
3/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
75.0%
3/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
General disorders
Infusion Site Pain
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
General disorders
Asthenia
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
General disorders
Chest Pain
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
General disorders
Chills
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
General disorders
Feeling Hot
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
50.0%
2/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
50.0%
2/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Investigations
Neutrophil Count Decreased
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Cardiac disorders
Myocardial Infarction
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Injury, poisoning and procedural complications
Metal Fume Fever
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Vascular disorders
Hot Flush
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
16.7%
1/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
0.00%
0/6 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
25.0%
1/4 • Baseline up to Day 150
The safety population was defined as the group of participants who received any dose of the study drug (ALXN1210 or placebo).
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place