NCT05288673

A Study of Multiple Doses of ALXN1210 in Healthy Adult Participants

A Phase 1, Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Healthy 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 multiple doses of ALXN1210 (400 and 800 milligrams \[mg\]) following intravenous (IV) administration to healthy participants.

Detailed description

Participants were divided into 2 cohorts and were randomly assigned in a 3:1 ratio to receive IV ALXN1210 or placebo. Participants in Cohort 1 received 5 IV doses of 400 mg of ALXN1210 or placebo administered every 28 days. To determine if dose continuation and dose escalation to Cohort 2 should occur, the Safety Review Committee conducted a blinded review of the available safety data after Day 15 of the second dose of the last participant in Cohort 1. Participants in Cohort 2 received 5 doses of 400 mg of ALXN1210 or placebo and 5 IV doses of 800 mg of ALXN1210 or placebo administered intravenously every 28 days. Safety, PK, PD, and immunogenicity assessments were performed during the Follow-up Period after the last dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1210	ALXN1210 was administered by IV infusion over 5 periods, 1 dose per period: Period 1, induction; Periods 2-5, maintenance. Participants received a total of 5 doses of 400 or 800 mg, each administered every 28 days.
DRUG	Placebo	Placebo was administered by IV infusion over 5 periods, 1 dose per period. Participants received the same volume and infusion rate as specified for each ALXN1210 dose (400 or 800 mg).

Timeline

• Start date: 2015-07-28
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2022-03-21
• Last updated: 2023-05-09
• Results posted: 2023-05-09

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study