NCT05254613

A Study of Single and Multiple SC Doses 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: 12 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.

Detailed description

This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).

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: 2019-11-12
• Primary completion: 2021-01-22
• Completion: 2021-01-22
• First posted: 2022-02-24
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study