A Single-blind, Placebo Controlled, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3389934 Intravenous Infusions in Healthy Japanese Participants.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Japan
SOUSEIKAI Fukuoka Mirai Hospital
RECRUITING
Fukuoka
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 16
Treatments
Experimental: Dose Step 1 BAY 3389934
15 mg/h/ intravenous Single Dose for 4 h fasting
Experimental: Dose Step 2 BAY 3389934
Max. dose 35 mg / h / intravenous - actual dose will be determined after Dose Step 1 Single Dose for 4 h fasting
Placebo_comparator: Dose Step 1 and Dose Step 2 Placebo
Placebo / intravenous Single Dose for 4 h Fasting
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov