NCT06258720

A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

Interventional, Randomized, Open-label, Parallel-group, Single-dose Trial Investigating the Safety, Immunogenicity, Tolerability, and Pharmacokinetic Properties of Lu AF82422 in Healthy Chinese and Caucasian Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Lu AF82422	Lu AF82422 solution for intravenous infusion

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2024-02-14
• Last updated: 2024-11-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study