A Study to Test How Different Doses of BI 3814916 Are Tol... | NCT07486115

Studies
A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People

NCT07486115

Sponsor

Boehringer Ingelheim

Status

Recruiting

Last Update Posted

May 28, 2026Actual

Enrollment

136Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

BI 3814916
Placebo matching BI 3814916

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-523262-25-00	EU Trial (CTIS) Number
1111-1325-7389	Registry Identifier	WHO - International Clinical Trials Registry Platform (ICTRP)

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2026Actual

Primary Completion Date

Jul 12, 2027Estimated

Completion Date

Jul 12, 2027Estimated

First Submitted Date

Mar 17, 2026

First Submission Date that Met QC Criteria

Mar 17, 2026

First Posted Date

Mar 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2026

Last Update Posted Date

May 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI 3814916	Biological	BI 3814916	Part A: single rising dose arm Part B: multiple rising dose arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator		up to 111 days

Secondary Outcomes

Measure	Description	Time Frame
Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)		up to 72 days
Part A: Maximum measured concentration of the analyte in serum (Cmax)		up to 72 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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.

Exclusion criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Boehringer Ingelheim	Contact	1-800-243-0127		clintriage.rdg@boehringer-ingelheim.com

Facility	Status	City	State	ZIP	Country	Contacts
SGS Life Science Services - Clinical Research	Recruiting	Edegem		2650	Belgium

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided