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 — DRUGBI 765423
- Placebo — DRUGPlacebo
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 groupBI 765423
- Placebo Comparator: Placebo groupPlacebo
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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