CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
ALXN1210 +1 moredrug
Likely dose
ALXN1210 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05288673
NCT05288673Phase 1Completed
CompareCT.gov

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

Alexion Pharmaceuticals, Inc.·interventional·Posted Mar 21, 2022·Updated May 9, 2023

In Brief

A Phase 1 clinical trial evaluating ALXN1210 and Placebo for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 21, 2022
Enrollment StartJul 28, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.3 years ago

Interventions

ALXN1210drug

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.

Placebodrug

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).