Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants
Study identifier:ALXN2080-HV-101
ClinicalTrials.gov identifier:NCT05428696
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ALXN2080, Placebo
Sex
All
Actual Enrollment
90
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 12 Sept 2022
Primary Completion Date: 24 Apr 2023
Study Completion Date: 26 May 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
Celerion
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: SAD - Cohort 1 Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: SAD - Cohort 2 Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: SAD - Cohort 3 Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: SAD - Cohort 4 Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: SAD - Cohort 5 Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: SAD - Cohort 6 Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: MAD - Cohort 1 Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: MAD - Cohort 2 Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: MAD - Cohort 3 Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
| Experimental: MAD - Cohort 4 Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. | Drug: ALXN2080 Powder-in-capsule Drug: Placebo Powder-in-capsule |
