Actively Recruiting
A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.
Led by Bayer · Updated on 2026-03-31
16
Participants Needed
2
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 when given at different doses. BAY 3389934 is being developed for the potential treatment of a serious blood clotting condition called sepsis-associated disseminated intravascular coagulation (DIC). The research will be conducted as a single-blind, placebo-controlled, dose-escalation study. This means that participants will be randomly assigned to receive either the active drug (BAY 3389934) or a placebo (an inactive substance), and they will not know which one they are receiving. The study will involve up to 16 healthy male and female Japanese participants, aged between 18 and 55. The study consists of two parts, called dose steps. In the first step, participants will receive a single 4-hour intravenous (IV) infusion of BAY 3389934 at a dose of 15 mg/h, or a placebo. Based on the safety and tolerability results from this first step, a second, higher dose will be selected for the next group of participants in the second step. Throughout the study, researchers will closely monitor participants for any side effects (adverse events). They will also collect blood and urine samples to study how the drug is absorbed, distributed, and eliminated by the body (pharmacokinetics or PK) and what effects it has on the body's clotting system (pharmacodynamics or PD). This involves measuring specific substances in the blood, such as activated partial thromboplastin time (aPTT) and prothrombin time (PT). Participants will stay at the study center for 4 days and will have a follow-up visit 3 to 5 days after they are discharged. The information gathered from this study is crucial for the future clinical development of BAY 3389934 in Japan and for designing future studies in patients with septic DIC.
CONDITIONS
Official Title
A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years inclusive
- Healthy Japanese individuals as confirmed by medical evaluation
- Body mass index (BMI) between 18 and 29.9 kg/m8
- 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 women of nonchildbearing potential (WONCBP)
- Able to provide signed informed consent
- Willing to follow all study requirements and restrictions
You will not qualify if you...
- Any medical disorder, condition, or history that would impair participation
- Known allergy to the study drug or its ingredients
- Known bleeding disorders or congenital/acquired coagulation disorders
- Use of prescription, over-the-counter, or herbal drugs within 14 days or 5 half-lives before the study
- Clinically relevant ECG abnormalities, including 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 test for Hepatitis B, Hepatitis C, or HIV
- Positive drug screening, alcohol breath test, or urine cotinine test
- Clinically significant abnormal lab results at screening
- Positive pregnancy test
- Blood or plasma donation within specified timeframes before the study
- Non-compliance with lifestyle restrictions (e.g., alcohol, certain foods, strenuous activity)
- Participation in another clinical study within specified timeframes
AI-Screening
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Trial Site Locations
Total: 2 locations
1
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Fukuoka Pref, Japan, 813-0017
Actively Recruiting
2
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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