NCT06081530

A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

Single-blind, Randomised, Placebo-Controlled Trial on the Safety, Tolerability, and Pharmacokinetics of Single Rising Doses and Multiple Doses of Intravenous BI 3802876 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 3802876	BI 3802876
DRUG	Placebo matching BI 3802876	Placebo matching BI 3802876

Timeline

• Start date: 2023-10-27
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2023-10-13
• Last updated: 2025-04-09

Locations

1 site across 1 country: Belgium