DS Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants
Study identifier:ALXN1910-HV-101
ClinicalTrials.gov identifier:1231321
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
DS A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1910 in Healthy Adult Participants
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ALXN1910, Placebo
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 12 Apr 2022
Primary Completion Date: 07 Feb 2023
Study Completion Date: 07 Feb 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science
Verification:
Verified 01 Feb 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 Participants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV. | Drug: ALXN1910 Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. Drug: Placebo Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
| Experimental: Cohort 2 Participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. | Drug: ALXN1910 Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. Drug: Placebo Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
| Experimental: Cohort 3 Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV. | Drug: ALXN1910 Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. Drug: Placebo Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
| Experimental: Cohort 4 Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. | Drug: ALXN1910 Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. Drug: Placebo Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
| Experimental: Cohort 5 Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC. | Drug: ALXN1910 Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. Drug: Placebo Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
| Experimental: Cohort 6 Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC. | Drug: ALXN1910 Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. Drug: Placebo Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
