Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants

Study identifier:ALXN1910-HV-101

ClinicalTrials.gov identifier:NCT05307978

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Female & Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 12 Apr 2022

Primary Completion Date: 07 Feb 2023

Study Completion Date: 02 Mar 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Triple
Primary Purpose: Basic Science

Verification:

Verified 01 Mar 2023 by Alexion Pharmaceuticals, Inc.

Collaborators

Inclusion and exclusion criteria

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.	-
Experimental: Cohort 3 Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV.	-
Experimental: Cohort 4 Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.	-
Experimental: Cohort 5 Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC.	-
Experimental: Cohort 6 Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC.	-