NCT05501717

Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.

Detailed description

Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN2030	ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
DRUG	Placebo	Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.

Timeline

• Start date: 2022-08-16
• Primary completion: 2025-10-09
• Completion: 2026-10-14
• First posted: 2022-08-15
• Last updated: 2026-04-09

Locations

1 site across 1 country: United Kingdom