A Study to Test How Well Multiple Doses of BI 765423 Are Tolerated by Healthy Men

Sponsor
Boehringer Ingelheim
Study ID
NCT06232252
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 765423 in healthy male subjects.

Key Dates

Start date
May 6, 2024
Status verified
Jun 2025
Primary completion
Apr 25, 2025
Completion
Apr 29, 2025

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose group (DG) 1 (very low dose)
  • Experimental: Dose group (DG) 2 (low dose)
  • Experimental: Dose group (DG) 3 (medium dose)
  • Experimental: Dose group (DG) 4 (high dose)

Primary Outcome Measure

Percentage of subjects treated with BI 765423 who experience any treatment-emergent adverse event assessed as drug-related by the investigator [ Time Frame: up to 145 days for DG 1 and 2, up to 159 days for DG 3 and 4 ]

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