New drug BI 3006337 tested in healthy volunteers for safety
NCT ID NCT05076422
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a single injection of the experimental drug BI 3006337 in 80 healthy men to see if it is safe and how the body processes it. Participants received either the drug or a placebo, and researchers monitored side effects and drug levels in the blood. Since this is a Phase 1 study in healthy people, it does not aim to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 3006337
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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80 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Mar 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (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. * 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 Exclusion Criteria: * 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 * 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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ICON
Groningen, 9728 NZ, Netherlands
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SGS Life Science Services - Clinical Research
Edegem, 2650, Belgium
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