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A Study of Multiple Doses of ALXN1210 in Healthy Adult Participants

Healthy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05288673
Study type Interventional
Source Alexion
Contact
Status Completed
Phase Phase 1
Start date July 28, 2015
Completion date September 1, 2016
View Details
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