HealthyPhase 1NCT05076422

A Study to Test How Well Men Tolerate Different Doses of BI 3006337

A Phase 1 study testing BI 3006337 in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.

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 and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy 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: 80 participants
Where: 2 sitesin 2 countries
Study dates: 18 Oct 2021to 3 Mar 2023
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 55 years
Men only
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 (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
Age of ≥18 to ≤55 years at screening (SCR)
BMI of ≥20.0 to <32.0 kg/m2 at SCR
A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR
Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication:
Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom or sexually abstinence (if lifestyle-related): implants, injectables, vaginal contraceptives, intrauterine device, oral contraception (failure rate <1%). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

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Surgically sterilised/vasectomised (including hysterectomy with or without bilateral salpingectomy or bilateral oophorectomy of female partner. In case of salpingectomy or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment).
Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea.
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Female gender
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
3 times repeated measurement of systolic BP outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 40 to 100 bpm. In case of documented white coat hypertension the decision for eligibility is left to the investigator.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters Alanine Transaminase (ALT) (1.25xupper limit of normal (ULN)), Aspartate Transaminase (AST) (1.25xULN) and Total Bilirubin (T-BIL) (1.5xULN) or renal parameters (creatinine 1.25xULN) exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated measurements
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

Show all 10Show fewer

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
Chronic or relevant acute infections, including positive tests for Hepatitis (Hep) B antigen/ Hep C antibodies, Human immunodeficiency virus (HIV)-1/2 antibodies and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Further exclusion criteria apply

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Belgium1 site

SGS Life Science Services - Clinical Research
Edegem, 2650

Other trials in Belgium

Netherlands1 site

ICON
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.

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 NCT05076422
Study group	Role	What they receive
BI 3006337 0.2 mg	Experimental	Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 0.5 mg	Experimental	Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 1 mg	Experimental	Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 2 mg	Experimental	Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 4 mg	Experimental	Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 8 mg	Experimental	Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 15 mg	Experimental	Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 30 mg	Experimental	Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 50 mg	Experimental	Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 100 mg	Experimental	Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
BI 3006337 150 mg	Experimental	Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: BI 3006337
Placebo	Placebo comparator	This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. Receives: Drug: Placebo

What is being measured

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

Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Measured: From 1 day pre-dose till end of trial, up to 40 days

Secondary outcomes (3)

Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞).
Measured: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Maximum Measured Concentration of BI 3006337 in Serum (Cmax)
Maximum measured concentration of BI 3006337 in serum (Cmax) is reported.
Measured: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)
Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported.
Measured: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.

Timeline

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

18 Oct 20213 Mar 2023

First posted13 Oct 2021
Study start18 Oct 2021
Primary completion3 Mar 2023
Study completion3 Mar 2023

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
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05076422
Sponsor's protocol ID: 1466-0001
Other IDs: 2020-002600-38
Status last verified: Dec 2025
First submitted: 5 Oct 2021
Last updated: 8 Jan 2026
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, except for the following exclusions:1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of 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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. 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 of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)
ClinicalTrials.gov ID: NCT05076422
Acronym / sponsor ID: 1466-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Oct 2021 (actual)
Primary completion: 3 Mar 2023 (actual)
Study completion: 3 Mar 2023 (actual)
First posted: 13 Oct 2021 (actual)
Results: Posted 8 Jan 2026

Clinical summary

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

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 12

Arm	Type	Receives
BI 3006337 0.2 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 0.5 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 1 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 2 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 4 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 8 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 15 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 30 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 50 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 100 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
BI 3006337 150 mg	Experimental	Drug: BI 3006337Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
Placebo	Placebo comparator	Drug: PlaceboThis arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
Age of ≥18 to ≤55 years at screening (SCR)
BMI of ≥20.0 to <32.0 kg/m2 at SCR
A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR
Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication:

Key exclusion criteria (10 listed)

Female gender
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
3 times repeated measurement of systolic BP outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 40 to 100 bpm. In case of documented white coat hypertension the decision for eligibility is left to the investigator.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters Alanine Transaminase (ALT) (1.25xupper limit of normal (ULN)), Aspartate Transaminase (AST) (1.25xULN) and Total Bilirubin (T-BIL) (1.5xULN) or renal parameters (creatinine 1.25xULN) exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated measurements
Any evidence of a concomitant disease assessed as clinically relevant by the investigator

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	BI 3006337 0.2 mg, BI 3006337 0.5 mg, BI 3006337 1 mg, BI 3006337 100 mg, BI 3006337 15 mg, BI 3006337 150 mg, BI 3006337 2 mg, BI 3006337 30 mg, BI 3006337 4 mg, BI 3006337 50 mg, BI 3006337 8 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337
Time frame: From 1 day pre-dose till end of trial, up to 40 days
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.

3 secondary outcomes

Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Maximum Measured Concentration of BI 3006337 in Serum (Cmax)
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.

Results and safety

Results posted to the registry on 8 Jan 2026, 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	19	19
BI 3006337 0.2 mg	5	5
BI 3006337 0.5 mg	6	6
BI 3006337 1 mg	5	5
BI 3006337 2 mg	6	6
BI 3006337 4 mg	5	5
BI 3006337 8 mg	4	4
BI 3006337 15 mg	5	5
BI 3006337 30 mg	4	4
BI 3006337 50 mg	6	6
BI 3006337 100 mg	6	6
BI 3006337 150 mg	9	9

Primary outcome: Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337

Time frame: From 1 day pre-dose till end of trial, up to 40 days. Count of participants. Unit: Participants

Measure	Placebo n = 19	BI 3006337 0.2 mg n = 5	BI 3006337 0.5 mg n = 6	BI 3006337 1 mg n = 5	BI 3006337 2 mg n = 6	BI 3006337 4 mg n = 5	BI 3006337 8 mg n = 4	BI 3006337 15 mg n = 5	BI 3006337 30 mg n = 4	BI 3006337 50 mg n = 6	BI 3006337 100 mg n = 6	BI 3006337 150 mg n = 9
Value	0	0	1	0	0	2	0	0	0	2	1	1

Population analysed: Treated set (TS): The treated set included all subjects who were entered and treated with any dose of the trial drug or placebo.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From 1 day pre-dose till end of trial, up to 40 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 19 (0%)	9 of 19 (47.4%)	0 of 19
BI 0.2mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
BI 0.5mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 1mg	0 of 5 (0%)	1 of 5 (20%)	0 of 5
BI 2mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
BI 4mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
BI 8mg	0 of 4 (0%)	0 of 4 (0%)	0 of 4
BI 15mg	0 of 5 (0%)	0 of 5 (0%)	0 of 5
BI 30mg	0 of 4 (0%)	0 of 4 (0%)	0 of 4
BI 50mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 100mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BI 150mg	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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, except for the following exclusions:1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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.

2 sites in 2 countries: 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 2 sites in 2 countries.

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 9 inclusion and 10 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Netherlands. 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 8 Jan 2026). 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 Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 (time frame: From 1 day pre-dose till end of trial, up to 40 days). 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 NCT05076422.

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 8 Jan 2026.