NCT04730804

A Study of ALXN1830 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

Detailed description

This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1830	ALXN1830 will be administered as SC infusion(s).
DRUG	Placebo	Placebo will be administered as SC infusion(s).

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-12-14
• Completion: 2022-01-04
• First posted: 2021-01-29
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

2 sites across 1 country: New Zealand

Regulatory

• FDA-regulated drug study