At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
BI 765080 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Intravenous Doses of BI 765080 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel-group Design)
In Brief
A Phase 1 clinical trial evaluating BI 765080 and Placebo for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartJan 2021
Primary CompletionAug 2021
TodayJul 2026
First PostedDec 14, 2020
Enrollment StartJan 14, 2021
Primary CompletionAug 25, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.5 years ago
Interventions
BI 765080drug
BI 765080
Placebodrug
Placebo; 0.9% saline for injection