A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2

Sponsor
Boehringer Ingelheim
Study ID
NCT04384081
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
20 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • BI 456906 — DRUG
    Solution for injection
  • Placebo — DRUG
    Solution for injection

Study Details

Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies.

Key Dates

Start date
Jun 1, 2020
Status verified
Jan 2021
Primary completion
Nov 17, 2020
Completion
Jan 20, 2021

Study Design

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

Arms

  • Experimental: Dose group 1
  • Experimental: Dose group 2
  • Experimental: Dose group 3
  • Placebo Comparator: Placebo group

Primary Outcome Measure

Cumulative percentage (%) of subjects withdrawn from up-titration by dose escalation scheme. [ Time Frame: up to 113 days ]

Related Studies