NCT05177029

Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants

Interventional, Randomized, Double-Blind, Sequential-Part, Placebo-Controlled, Single- and Multiple-Dose Study Investigating Safety, Tolerability, and Pharmacokinetic Properties of Lu AG06466 in Healthy Young Japanese and Caucasian Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main goal of this study is to evaluate the effect of Lu AG06466 on the body and what the body does to Lu AG06466 after single and multiple doses to healthy Japanese and Caucasian participants.

Detailed description

This sequential study will be divided in two parts, Part A and Part B. Part A will consist of 3 cohorts (Cohorts A1, A2, and A3) in which participants will be randomized to receive a single dose of Lu AG046466 or a matching placebo orally. After completing the safety review of data from Cohort A1, the study will proceed in Cohorts A2 and A3, with an increased dose of Lu AG046466 or matching placebo being administered to Japanese and Caucasian participants. Part B dosing will only be initiated after completion of Part A. Part B will consist of 1 cohort (Cohort B1), to which multiple dose of Lu AG046466 or matching placebo will be administered after dose titration.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lu AG06466	Lu AG06466 will be administered per schedule specified in the arm.
DRUG	Placebo	Placebo matching to Lu AG06466 will be administered per schedule specified in the arm.

Timeline

• Start date: 2021-11-26
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2022-01-04
• Last updated: 2022-07-12

Locations

1 site across 1 country: Japan