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

Healthy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05428696
Study type Interventional
Source Alexion
Contact
Status Completed
Phase Phase 1
Start date September 12, 2022
Completion date May 26, 2023
View Details
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