Status:
RECRUITING
A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.
Lead Sponsor:
Bayer
Conditions:
Sepsis Associated Disseminated Intravascular Coagulation (DIC)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body ...
Eligibility Criteria
Inclusion
- Participant must be 18 to 55 years of age inclusive.
- Participants who are overtly healthy Japanese as determined by medical evaluation.
- Body mass index (BMI) within the range 18 - 29.9 kg/m² (inclusive).
- Male participants must agree to use specified contraception during the study and for at least 90 days plus 5 half-lives after.
- Female participants must be a Woman of Nonchildbearing Potential (WONCBP).
- Capable of giving signed informed consent.
- Willing to comply with the requirements and restrictions listed in the protocol.
Exclusion
- Any medical disorder, condition, or history that would impair participation.
- Known hypersensitivity to the study drug or its excipients.
- Known disorders with increased bleeding risk or known congenital/acquired coagulation disorders.
- Use of prescription drugs, over-the-counter drugs, or herbal products within 14 days or 5 half-lives before the study.
- Clinically relevant findings in the ECG, such as a QTcF over 450 msec.
- Systolic blood pressure below 90 mmHg or above 140 mmHg at screening and admission.
- Diastolic blood pressure below 40 mmHg or above 90 mmHg at screening and admission.
- Positive results for Hepatitis B, Hepatitis C, or HIV.
- Positive drug screening, alcohol breath test, or urine cotinine test.
- Clinically relevant deviations of the screened laboratory parameters from reference ranges at the screening visit.
- Positive pregnancy test.
- Donation of blood or plasma within specified timeframes before the study.
- Lack of compliance with lifestyle restrictions (e.g., alcohol, specific foods, strenuous activity).
- Previous participation in this or another clinical study within a specified timeframe.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07176728
Start Date
September 22 2025
End Date
January 30 2026
Last Update
January 5 2026
Active Locations (2)
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1
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Fukuoka Pref, Japan, 813-0017
2
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017