A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated (NCT06310005) | Clinical Trial Compass
CompletedPhase 1
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated
Japan36 participantsStarted 2024-04-19
Plain-language summary
The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \< 10 years, and have parents and grandparents who are Japanese
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of injection of trial medication until 30 days after end of injection of trial medication:
* Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
* Vasectomized (vasectomy at least 1 year prior to enrolment)
* Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner
* Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause
Exclusion Criteria:
* …
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Timeframe: SRD part: From BI 3006337 administration until end of residual effect period (REP), 3 weeks. MD part: From first until last BI 3006337 administration + REP, up to 9 weeks.