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NCT07908004
A Study to Test How Well Different Doses of BI 3821001 Are Tolerated by Healthy People
Conditions: Healthy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Boehringer Ingelheim
Location: CRS Clinical Research Services Berlin GmbH Berlin
Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 administrations of multiple rising doses.
Eligibility Criteria
Inclusion Criteria:
* Healthy male or female of non-childbearing potential trial participant 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 \[PR\]), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Aged 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.
Exclusion Criteria:
* 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 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 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07908004). StuddyBuddy aggregates publicly available trial information.