NCT04940949

A Study to Evaluate Lu AF90103 in Healthy Men

Interventional, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study Part Investigating the Safety, Tolerability, and Pharmacokinetic and -Dynamic Properties of Lu AF90103 and a Double-Blind, Cross-Over Study Part Investigating the Safety Profile After Infusion of Lu AF90103 at Two Rates to Healthy Men

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and tolerability of Lu AF90103 and what the body does to Lu AF90103 after single doses of the drug administered directly into a vein.

Detailed description

This study is the first-in-human (FIH) study with Lu AF90103. The study is divided in two parts, Part A and Part B. Part A is an interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Lu AF90103 in healthy men. Part B is an interventional, randomized, double-blind, cross-over study to investigate the safety profile after administration of Lu AF90103 as an infusion at two different rates to healthy young men. The dosage in Part B is guided by the cohorts in Part A and is a repetition of one of the doses from Part A. The total study duration per participant from baseline to the end of follow-up will be maximum 11 days in Part A and 16 days in Part B.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lu AF90103	Lu AF90103 - powder for solution for infusion
DRUG	Placebo	Placebo - powder for solution for infusion

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2021-06-28
• Last updated: 2023-03-16

Locations

1 site across 1 country: Netherlands