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

NCT06310005 | Completed Phase 1 Results

• 1 other identifier: 1466-0003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAE)

  Number of participants with treatment-emergent adverse events (TEAE) is presented.

  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.

Secondary Outcomes (4)

• Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

  Within 3 hours (hrs) before BI 3006337 administration and at 1.5, 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, and 672 hrs, and at end of trial examination, up to Day 40 after BI 3006337 administration.

• Maximum Measured Concentration of BI 3006337 in Serum (Cmax)

  Within 3 hours (hrs) before BI 3006337 administration and at 1.5, 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, and 672 hrs, and at end of trial examination, up to Day 40 after BI 3006337 administration.

• Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Dosing Interval Tau at Steady State (AUCtau, ss) After the Last Dose in Week 6

  Within 3 hours (hrs) before last BI 3006337 administration and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, and 168 hrs after last BI 3006337 administration.

• Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax, ss) After the Last Dose in Week 6

  Within 3 hours (hrs) before last BI 3006337 administration and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, and 168 hrs after last BI 3006337 administration.

Study Arms (6)

Placebo (SRD)

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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

Drug: BI 3006337

SRD part: BI 3006337 medium dose

EXPERIMENTAL

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

Drug: BI 3006337

SRD part: BI 3006337 high dose

EXPERIMENTAL

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

Drug: BI 3006337

Placebo (MD)

PLACEBO COMPARATOR

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

Drug: Placebo

Multiple dose part (MD): BI 3006337 high dose

EXPERIMENTAL

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

Drug: BI 3006337

Interventions

BI 3006337 DRUG

BI 3006337

Multiple dose part (MD): BI 3006337 high dose; SRD part: BI 3006337 high dose; SRD part: BI 3006337 medium dose; Single-rising dose part (SRD): BI 3006337 low dose

Placebo DRUG

Placebo

Placebo (MD); Placebo (SRD)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Clinical Research Hospital Tokyo

Tokyo, Shinjuku-ku, 160-0004, Japan

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The trial is designed single-blind. The treatments administered (BI 3006337 or placebo) will be blinded to subjects but will be known to the investigators (outcome assessors).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Trial consists of a single-rising dose (SRD) and multiple dose (MD) part. In SRD part, the groups will be dosed consecutively in ascending order. The decision proceeding to MD part will be based upon safety and tolerability of all the preceding dose groups in SRD part. Within each dose group, patients will be randomized to either BI 3006337 or placebo.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 13, 2024
• Study Start: April 19, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)