NCT05288816

A Study of Single and Multiple Doses of ALXN1210 in Healthy, Adult Japanese Participants

A Phase 1, Open-Label, Single Ascending and Multiple Set Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study evaluated the safety and tolerability of single and multiple doses (400 and 800 milligrams \[mg\]) of ALXN1210 following intravenous administration to healthy Japanese participants.

Detailed description

A total of 3 cohorts were enrolled sequentially. Participants received different doses per Cohorts: Cohort 1, 400 mg single dose; Cohort 2, 800 mg single dose; and Cohort 3, 800 mg every 4 weeks for a total of 5 doses. The Safety Review Committee (SRC) conducted a review of the available clinical and safety data after the last participants in the 400 mg cohort (Cohort 1) completed Day 15 to determine if dose escalation to the single dose 800 mg (Cohort 2) could proceed. The SRC then conducted a review of all available clinical and safety data after the last participants in Cohort 2 completed Day 15 to determine if dosing of Cohort 3 could begin. A 120-day (Cohort 1) or 140-day (Cohort 2) Follow-up Period was performed for safety, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity assessments. Participants in Cohort 3, however, had a 185-day Follow-up Period for safety, PK, PD, and immunogenicity assessments after the fifth dose of study drug.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1210	Participants received a single dose (400 mg or 800 mg) and multiple doses (800 mg) of ALXN1210.

Timeline

• Start date: 2016-04-18
• Primary completion: 2017-07-05
• Completion: 2017-07-05
• First posted: 2022-03-21
• Last updated: 2024-02-05
• Results posted: 2024-02-05

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study