A Study to Test How Different Doses of BI 765423 Are Taken up in the Body of Healthy Men

Sponsor
Boehringer Ingelheim
Study ID
NCT05658107
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BI 765423 — DRUG
    BI 765423
  • Placebo — DRUG
    Placebo

Study Details

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765423 in healthy male subjects following intravenous administration of single rising doses.

Key Dates

Start date
Jan 16, 2023
Status verified
Apr 2024
Primary completion
Mar 19, 2024
Completion
Mar 19, 2024

Study Design

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

Arms

  • Experimental: BI 765423 treatment group
    BI 765423
  • Placebo Comparator: Placebo group
    Placebo

Primary Outcome Measure

Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [ Time Frame: up to 183 days ]

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