NCT03175211CompletedPhase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 456906 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- [N (%)] of subjects with drug-related adverse events.
Study Overview
Brief Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses.
The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 456906
Experimental
Intervention: BI 456906 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
[N (%)] of subjects with drug-related adverse events.
Time Frame: Up to 672 hours
Secondary Outcomes
- Cmax (maximum measured concentration of the analyte in plasma)(up to 672 hours)
- AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)(up to 168 hours)
Investigators
Study Sites (1)
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