A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3006337; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06310005

1466-0003

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm at screening visit
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 6 patient groups, including a placebo group

Placebo (SRD)

Placebo Comparator group

Description:

Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.

Treatment:

Drug: Placebo

Single-rising dose part (SRD): BI 3006337 low dose

Experimental group

Description:

Participants received one single low dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.

Treatment:

Drug: BI 3006337

SRD part: BI 3006337 medium dose

Experimental group

Description:

Participants received one single medium dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.

Treatment:

Drug: BI 3006337

SRD part: BI 3006337 high dose

Experimental group

Description:

Participants received one single high dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.

Treatment:

Drug: BI 3006337

Placebo (MD)

Placebo Comparator group

Description:

Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).

Treatment:

Drug: Placebo

Multiple dose part (MD): BI 3006337 high dose

Experimental group

Description:

Participants received one high dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).

Treatment:

Drug: BI 3006337