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New drug BI 3814916 begins first human safety tests

NCT ID NCT07486115

Knowledge-focused Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called BI 3814916 in 136 healthy adults to see if it is safe and how the body processes it. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and measure drug levels in the blood. This study is not designed to treat any disease but to gather essential safety information for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 3814916

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Age of 18 to 65 years (inclusive) at the time of screening 2. Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening 3. 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 4. Agree to refrain from strenuous or unusual exercise/activity (for example heavy lifting, weight training, intense aerobics classes, etc.) for at least 72 hours prior to study visits. 5. Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits. Further inclusion criteria apply. Exclusion criteria: 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature or electrocardiogram (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 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • SGS Life Science Services - Clinical Research

    RECRUITING

    Edegem, 2650, Belgium

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