HealthyPhase 1NCT07486115
A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People
A Phase 1 study testing BI 3814916 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
Trial summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 3814916
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteBelgium
- Study dates
- 20 May 2026to 12 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 to 65 years (inclusive) at the time of screening
- Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
- 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
- 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.
- 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.
Who cannot join
- 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
- 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)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
SGS Life Science Services - Clinical Research
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
About this study
Official title: A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BI 3814916 in Healthy Male and Female Subjects
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.
- Conditions
- Healthy
- Being tested
- BI 3814916, Placebo matching BI 3814916
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3814916Biological
BI 3814916
Placebo matching BI 3814916Drug
Placebo matching BI 3814916
| Study group | Role | What they receive |
|---|---|---|
| Part A: single rising dose arm | Experimental | Not described Receives: Biological: BI 3814916 |
| Part A: placebo arm | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3814916 |
| Part B: multiple rising dose arm | Experimental | Not described Receives: Biological: BI 3814916 |
| Part B: placebo arm | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3814916 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator
Measured: up to 111 days
Secondary outcomes (4)
Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 72 days
Part A: Maximum measured concentration of the analyte in serum (Cmax)
Measured: up to 72 days
Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss), if steady state can be reasonably assumed
Measured: up to 108 days
Part B: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss), if steady state can be reasonably assumed
Measured: up to 108 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 May 2026
- Primary completion12 Jul 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Part A: Single rising dose (SRD) Part B: Multiple rising dose (MRD)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486115
- Sponsor's protocol ID
- 1543-0001
- Other IDs
- 2025-523262-25-00, 1111-1325-7389, 2025
- Status last verified
- May 2026
- First submitted
- 17 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BI 3814916 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT07486115
- Acronym / sponsor ID
- 1543-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
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 (PK) of BI 3814916 in healthy male and female trial participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Part A: Single rising dose (SRD) Part B: Multiple rising dose (MRD)
| Arm | Type | Receives |
|---|---|---|
| Part A: single rising dose arm | Experimental | Biological: BI 3814916 |
| Part A: placebo arm | Placebo comparator | Drug: Placebo matching BI 3814916 |
| Part B: multiple rising dose arm | Experimental | Biological: BI 3814916 |
| Part B: placebo arm | Placebo comparator | Drug: Placebo matching BI 3814916 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 to 65 years (inclusive) at the time of screening
- Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
- 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
- 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.
- Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits.
Key exclusion criteria (4 listed)
- 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
- 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)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.
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 3814916BI 3814916 | Biological | Part A: single rising dose arm, Part B: multiple rising dose arm |
| Placebo matching BI 3814916Placebo matching BI 3814916 | Drug | Part A: placebo arm, Part B: placebo arm |
Primary outcome
Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator
Time frame: up to 111 days
4 secondary outcomes
Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 72 days
Part A: Maximum measured concentration of the analyte in serum (Cmax)
Time frame: up to 72 days
Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss), if steady state can be reasonably assumed
Time frame: up to 108 days
Part B: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss), if steady state can be reasonably assumed
Time frame: up to 108 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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.
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 3814916 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator (time frame: up to 111 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.