NCT05428696

Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants

A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

Detailed description

Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN2080	Powder-in-capsule
DRUG	Placebo	Powder-in-capsule

Timeline

• Start date: 2022-09-12
• Primary completion: 2023-04-24
• Completion: 2023-05-26
• First posted: 2022-06-23
• Last updated: 2024-06-07

Locations

1 site across 1 country: United Kingdom