HealthyPhase 1NCT06745297
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
A Phase 1 study testing BI 3776528 and short-acting benzodiazepine in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 3776528 and short-acting benzodiazepine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jan 2025to 3 May 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 50 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 and clinical laboratory.
- Age of 18 to 50 years (inclusive)
- BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Who cannot join
- Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator 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.
Germany1 site, 1 recruiting
- Recruiting
Charité Research Organisation GmbH
Berlin, 10117
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
About this study
Official title: A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Conditions
- Healthy
- Being tested
- BI 3776528, Placebo matching BI 3776528, short-acting benzodiazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3776528Drug
BI 3776528
Placebo matching BI 3776528Drug
Placebo matching BI 3776528
short-acting benzodiazepineDrug
short-acting benzodiazepine
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: BI 3776528; Drug: short-acting benzodiazepine |
| Placebo group | Placebo comparator | Applicable for part 1a and part 2 of the trial. Receives: Drug: Placebo matching BI 3776528; Drug: short-acting benzodiazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Measured: up to 62 days
Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 27 days
Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
Measured: up to 27 days
Secondary outcomes (6)
Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 27 days
Part 1a: Cmax of BI 3776528 in plasma
Measured: up to 27 days
Part 1b: AUC0-∞ of BI 3776528 in plasma
Measured: up to 27 days
Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 27 days
Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 27 days
Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start23 Jan 2025
- Primary completion3 Feb 2027 (estimated)
- Study completion3 May 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
- Sequential
- Model description
- This trial will be conducted in 2 parts: Part 1 (single doses) and Part 2 (multiple doses). Part 1 comprises of 2 subparts: Parts 1a and 1b. Part 1b starts only after the dose has been tested in part 1a and was safe and of acceptable tolerability. Part 2 of the study will only commence after the successful administration of the planned dose to the last subject in part 1a.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 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
- NCT06745297
- Sponsor's protocol ID
- 1526-0001
- Other IDs
- 2024-515222-92-00, U1111-1307-8288
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2024
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06745297
- Acronym / sponsor ID
- 1526-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 20 Dec 2024 (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 trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This trial will be conducted in 2 parts: Part 1 (single doses) and Part 2 (multiple doses). Part 1 comprises of 2 subparts: Parts 1a and 1b. Part 1b starts only after the dose has been tested in part 1a and was safe and of acceptable tolerability. Part 2 of the study will only commence after the successful administration of the planned dose to the last subject in part 1a.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: BI 3776528, Drug: short-acting benzodiazepine |
| Placebo group | Placebo comparator | Drug: Placebo matching BI 3776528, Drug: short-acting benzodiazepineApplicable for part 1a and part 2 of the trial. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory.
- Age of 18 to 50 years (inclusive)
- BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Key exclusion criteria (4 listed)
- Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator 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 3776528BI 3776528 | Drug | Treatment group |
| Placebo matching BI 3776528Placebo matching BI 3776528 | Drug | Placebo group |
| short-acting benzodiazepineshort-acting benzodiazepine | Drug | Placebo group, Treatment group |
Primary outcome
Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to 62 days
Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 27 days
Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
Time frame: up to 27 days
6 secondary outcomes
Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 27 days
Part 1a: Cmax of BI 3776528 in plasma
Time frame: up to 27 days
Part 1b: AUC0-∞ of BI 3776528 in plasma
Time frame: up to 27 days
Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 27 days
Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 27 days
Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 27 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 27 Oct 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 3776528 and short-acting benzodiazepine in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 4 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 27 Oct 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 Germany. 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?
Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator (time frame: up to 62 days). The study lists 3 primary outcomes in all. 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 27 Oct 2026.