NCT02852824CompletedPhase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects With Drug-related Adverse Events (AEs).
Study Overview
Brief Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 655130 (spesolimab)
Experimental
Intervention: BI 655130 (spesolimab) (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects With Drug-related Adverse Events (AEs).
Time Frame: From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)
Percentage of subjects with investigator defined drug-related adverse events (AEs).
Secondary Outcomes
- Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Pharmacokinetic samples were collected at 2 hours pre-dose and 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration.)
- Maximum Measured Concentration of the BI 655130 in Plasma (Cmax)(Up to 4200 hours. Individual time points are provided in detail in description.)
- Area Under the Concentration-time Curve of the BI 655130 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)(Up to 4200 hours. Individual time points are provided in detail in description.)
- Maximum Measured Concentration of BI 655130 in Plasma After the Fourth Dose (Cmax,4)(Up to 4200 hours. Individual time points are provided in detail in description.)
- Area Under the Concentration Time Curve of BI 655130 in Plasma After the Fourth Dose (AUCτ,4)(Up to 4200 hours. Individual time points are provided in detail in description.)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
This Study is Done in Healthy Chinese and Japanese Volunteers; it Looks at How BI 690517 is Taken up in the Body and How Well it is ToleratedHealthyNCT03206632Boehringer Ingelheim56
Completed
Phase 1
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 DaysHealthyNCT02733627Boehringer Ingelheim36
Completed
Phase 1
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the BloodHealthyNCT03100916Boehringer Ingelheim72
Completed
Phase 1
A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are ToleratedHealthyNCT03608072Boehringer Ingelheim36
Completed
Phase 1
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male VolunteersHealthyNCT03175211Boehringer Ingelheim20