CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
ALXN1210 +1 moredrug
Likely dose
ALXN1210 686 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/NCT05288660
NCT05288660Phase 1Completed

A Phase 1, Randomized, Blinded, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose 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 14 participants across 1 site.

Detailed Summary

This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory analysis, and assessment of adverse events (AEs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 21, 2022
Enrollment StartAug 27, 2014
Primary CompletionMar 13, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.3 years ago

Interventions

ALXN1210drug

All doses of ALXN1210 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 milliliters \[mL\]/hour), excluding interruption for safety or technical reason.

Placebodrug

All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 mL/hour), excluding interruption for safety or technical reason.