A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants
Study identifier:ALXN1830-HV-105
ClinicalTrials.gov identifier:NCT05254613
EudraCT identifier:2019‐003496‐18
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ALXN1830, Placebo
Sex
All
Actual Enrollment
12
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 12 Nov 2019
Primary Completion Date: 22 Jan 2021
Study Completion Date: 22 Jan 2021
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science
Verification:
Verified 01 Mar 2024 by Alexion Pharmaceuticals
Sponsors
Alexion Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 Participants will receive a single SC dose of ALXN1830 or placebo (750 mg). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
| Experimental: Cohort 2 Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
| Experimental: Cohort 3 Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
| Experimental: Cohort 4 Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
| Experimental: Cohort 5 Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
| Experimental: Cohort 6 Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
| Experimental: Cohort 7 Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total). | Drug: ALXN1830 ALXN1830 will be administered as SC infusion(s). Drug: Placebo Placebo will be administered as SC infusion(s). |
