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

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses and Multiple Subcutaneous Doses Over 6 Weeks of BI 3006337 in Healthy Male Japanese Subjects (Single-blind, Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 3006337

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Shinjuku-ku, Japan, 160-0004
    • Clinical Research Hospital Tokyo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (SRD); Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.	Drug: Placebo; Placebo
Experimental: Single-rising dose part (SRD): BI 3006337 low dose; Participants received one single low dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.	Drug: BI 3006337; BI 3006337
Experimental: SRD part: BI 3006337 medium dose; Participants received one single medium dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.	Drug: BI 3006337; BI 3006337
Experimental: SRD part: BI 3006337 high dose; Participants received one single high dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.	Drug: BI 3006337; BI 3006337
Placebo Comparator: Placebo (MD); Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).	Drug: Placebo; Placebo
Experimental: Multiple dose part (MD): BI 3006337 high dose; Participants received one high dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).	Drug: BI 3006337; BI 3006337

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf) is presented.	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)	Maximum measured concentration of BI 3006337 in serum (Cmax) is presented.	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	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 is presented.	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	Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6 is presented.	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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1466-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No