Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants
Study identifier:ALXN2030-HV-101
ClinicalTrials.gov identifier:NCT05501717
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ALXN2030, Placebo
Sex
All
Estimated Enrollment
48
Study type
Interventional
Age
18 Years - 60 Years
Date
Study Start Date: 16 Aug 2022
Estimated Primary Completion Date: 04 Feb 2025
Estimated Study Completion Date: 04 Feb 2025
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: ALXN2030 Dose A ALXN2030 will be administered as a single dose. | Drug: ALXN2030 ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
| Experimental: ALXN2030 Dose B ALXN2030 will be administered as a single dose. | Drug: ALXN2030 ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
| Experimental: ALXN2030 Dose C ALXN2030 will be administered as a single dose. | Drug: ALXN2030 ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
| Experimental: ALXN2030 Dose D ALXN2030 will be administered as a single dose. | Drug: ALXN2030 ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
| Experimental: ALXN2030 Dose E ALXN2030 will be administered as a single dose. | Drug: ALXN2030 ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
| Placebo Comparator: Placebo Placebo will be administered as a single dose. | Drug: Placebo Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
