HealthyPhase 1NCT06310005

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

A Phase 1 study testing BI 3006337 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 3006337
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteJapan
Study dates: 19 Apr 2024to 31 Oct 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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:

Show all 10Show fewer

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Japan1 site

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

Other trials in Japan

About this study

Official title: 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)

Conditions: Healthy
Being tested: BI 3006337, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 3006337Drug
BI 3006337
PlaceboDrug
Placebo

Study groups in NCT06310005
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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)). Receives: 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)). Receives: Drug: BI 3006337

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAE)
Number of participants with treatment-emergent adverse events (TEAE) is presented.
Measured: 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)
Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf) is presented.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 202431 Oct 2024

First posted13 Mar 2024
Study start19 Apr 2024
Primary completion31 Oct 2024
Study completion31 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06310005
Sponsor's protocol ID: 1466-0003
Status last verified: Dec 2025
First submitted: 8 Mar 2024
Last updated: 22 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06310005
Acronym / sponsor ID: 1466-0003
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 19 Apr 2024 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 13 Mar 2024 (actual)
Results: Posted 22 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 6
Model description: 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.

Arm	Type	Receives
Placebo (SRD)	Placebo comparator	Drug: PlaceboParticipants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
Single-rising dose part (SRD): BI 3006337 low dose	Experimental	Drug: BI 3006337Participants received one single low dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
SRD part: BI 3006337 medium dose	Experimental	Drug: BI 3006337Participants received one single medium dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
SRD part: BI 3006337 high dose	Experimental	Drug: BI 3006337Participants received one single high dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
Placebo (MD)	Placebo comparator	Drug: PlaceboParticipants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
Multiple dose part (MD): BI 3006337 high dose	Experimental	Drug: BI 3006337Participants received one high dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 3006337BI 3006337	Drug	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
PlaceboPlacebo	Drug	Placebo (MD), Placebo (SRD)

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: 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.
Number of participants with treatment-emergent adverse events (TEAE) is presented.

4 secondary outcomes

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

Results and safety

Results posted to the registry on 22 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (SRD)	6	6
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose	6	6
SRD Part: BI 3006337 100 mg Dose	6	6
SRD Part: BI 3006337 150 mg Dose	6	6
Placebo (MD)	3	3
Multiple Dose Part (MD): BI 3006337 150 mg Dose	9	9

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAE)

Time frame: 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.. Count of participants. Unit: Participants

Measure	Placebo (SRD) n = 6	Single-rising Dose Part (SRD): BI 3006337 50 mg Dose n = 6	SRD Part: BI 3006337 100 mg Dose n = 6	SRD Part: BI 3006337 150 mg Dose n = 6	Placebo (MD) n = 3	Multiple Dose Part (MD): BI 3006337 150 mg Dose n = 9
Value	4	4	2	2	0	8

Population analysed: Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (SRD)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
SRD Part: BI 3006337 100 mg Dose	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SRD Part: BI 3006337 150 mg Dose	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Placebo (MD)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Multiple Dose Part (MD): BI 3006337 150 mg Dose	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 3006337 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAE) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06310005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.