Healthy Clinical Trial - A Study to Evaluate Lu AF90103 in Healthy Men

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT04940949
Study type	Interventional
Source	H. Lundbeck A/S
Contact
Status	Terminated
Phase	Phase 1
Start date	May 26, 2021
Completion date	November 23, 2021

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