Healthy volunteers needed to test new Drug's safety
NCT ID NCT06575400
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This early-stage trial is testing a new drug called BI 3804379 in healthy adults to see if it is safe and how the body processes it. About 106 healthy men and women aged 18 to 65 will receive either the drug or a placebo as a shot under the skin. The study focuses on side effects and drug levels in the blood, not on treating any disease.
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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About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- 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 for Part A and Part B: 1. Healthy male or female (of non-child-bearing potential) participants 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), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 65 years (inclusive) 3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive) 4. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply Inclusion criteria for Part C: 1\. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply Exclusion criteria for Part A and Part B: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. 2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm). 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance. Further exclusion criteria apply Exclusion criteria for Part C: 1. Type 1 diabetes or uncontrolled type 2 diabetes (e.g., hemoglobin A1C (HbA1c) ≥10%, recent major treatment changes, or severe hypoglycemia). 2. Significant weight loss (≥10%) between diagnosis and screening. 3. Relevant surgery after diagnosis or planned during the study period. 4. Evidence of clinically significant or unstable disease increasing risk to the participant. 5. Severe renal impairment (estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²). 6. Uncontrolled hypertension or significant cardiovascular disease (e.g., recent myocardial infarction, stroke, or heart failure New York Heart Association (NYHA) class III/IV). 7. Clinically relevant ECG abnormalities, including QT interval corrected for heart rate (QTc) prolongation or risk factors for Torsade de Pointes. 8. Participation in another clinical trial or exposure to an investigational drug within 60 days prior to study treatment. Further exclusion criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SGS Life Science Services - Clinical Research
RECRUITINGEdegem, 2650, Belgium
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