CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 66 enrolled
Drug / intervention
ALXN1820 SC +3 moredrug
Likely dose
ALXN1820 SC 12.5 milligramsfrom 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/NCT04631562
NCT04631562Phase 1Completed

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants

Alexion Pharmaceuticals, Inc.·interventional·Posted Nov 17, 2020·Updated Aug 20, 2024

In Brief

A Phase 1 clinical trial evaluating ALXN1820 SC, ALXN1820 IV, and 2 other interventions for Healthy. Completed, enrolled 66 participants across 3 sites in 2 countries.

Detailed Summary

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesAustralia, United Kingdom
CollaboratorsSyneos Health

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedNov 17, 2020
Enrollment StartJan 13, 2021
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.6 years ago

Interventions

ALXN1820 SCdrug

ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.

ALXN1820 IVdrug

ALXN1820 IV (450 mg) will be administered as an IV infusion.

Placebo SCdrug

Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.

Placebo IVdrug

Placebo IV will be administered as an IV infusion.