NCT04631562

Study of ALXN1820 in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Detailed description

This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo. The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1820 SC	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.
DRUG	ALXN1820 IV	ALXN1820 IV (450 mg) will be administered as an IV infusion.
DRUG	Placebo SC	Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.
DRUG	Placebo IV	Placebo IV will be administered as an IV infusion.

Timeline

• Start date: 2021-01-13
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-11-17
• Last updated: 2024-08-20
• Results posted: 2024-03-15

Locations

3 sites across 2 countries: Australia, United Kingdom