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Completed

NCT Number: NCT05076422

A Study to Test How Well Men Tolerate Different Doses of BI 3006337

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services - Clinical Research, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
  • Age of ≥18 to ≤55 years at screening (SCR)
  • BMI of ≥20.0 to <32.0 kg/m2 at SCR
  • A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR
  • Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication:
  • Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom or sexually abstinence (if lifestyle-related): implants, injectables, vaginal contraceptives, intrauterine device, oral contraception (failure rate <1%). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
  • Surgically sterilised/vasectomised (including hysterectomy with or without bilateral salpingectomy or bilateral oophorectomy of female partner. In case of salpingectomy or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment).
  • Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea.
  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria

  • Female gender
  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • 3 times repeated measurement of systolic BP outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 40 to 100 bpm. In case of documented white coat hypertension the decision for eligibility is left to the investigator.
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters Alanine Transaminase (ALT) (1.25xupper limit of normal (ULN)), Aspartate Transaminase (AST) (1.25xULN) and Total Bilirubin (T-BIL) (1.5xULN) or renal parameters (creatinine 1.25xULN) exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated measurements
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections, including positive tests for Hepatitis (Hep) B antigen/ Hep C antibodies, Human immunodeficiency virus (HIV)-1/2 antibodies and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  • Further exclusion criteria apply

Treatment and study plan

BI 3006337

Drug

BI 3006337

Placebo

Drug

Placebo

Primary outcomes

  1. Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337

    Time frame: From 1 day pre-dose till end of trial, up to 40 days

    Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.

Secondary outcomes

  1. Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.

    Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞).

  2. Maximum Measured Concentration of BI 3006337 in Serum (Cmax)

    Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.

    Maximum measured concentration of BI 3006337 in serum (Cmax) is reported.

  3. Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)

    Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.

    Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2021
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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