Different doses of BAY 3389934 in healthy Japanese adults

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.

This will test different doses of BAY 3389934 to see how safe and tolerable the drug is in healthy Japanese adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Bayer (Industry-sponsored)
• Locations: 2 sites (Fukuoka, Fukuoka Pref and 1 other locations)
• Trial ID: NCT07176728 on ClinicalTrials.gov

What this trial studies

This single-blind, placebo-controlled, dose-escalation Phase 1 study gives BAY 3389934 or matching placebo to up to 16 healthy Japanese men and women aged 18–55 to characterize safety and tolerability. The study is organized in dose steps; in the first step participants receive a single 4-hour intravenous infusion of BAY 3389934 at 15 mg/h or placebo, with further dosing decisions guided by safety data. Participants must meet strict inclusion/exclusion criteria and will undergo clinical and laboratory monitoring for adverse events and pharmacodynamic measures. The primary focus is safety in healthy volunteers to inform future studies in patients with sepsis-associated DIC.

Who should consider this trial

Good fit: Ideal participants are healthy Japanese adults aged 18–55 with BMI 18–29.9 kg/m² who are willing to comply with study procedures and contraception requirements and meet screening lab criteria.

Not a fit: People with active medical conditions, known bleeding or coagulation disorders, current medication use, pregnant or breastfeeding women, or those who cannot meet eligibility criteria are excluded and are unlikely to receive any direct benefit from participating in this healthy-volunteer safety study.

Why it matters

Potential benefit: If successful, this could advance a new treatment candidate that may eventually reduce life-threatening clotting complications in patients with sepsis-associated DIC.

How similar studies have performed: While anticoagulation approaches have been explored for DIC, this is an early Phase 1 first-in-human dosing study for BAY 3389934 and the specific drug has not yet been proven effective in humans for DIC.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Fukuoka, Fukuoka Pref and 1 other locations

• SOUSEIKAI Fukuoka Mirai Hospital — Fukuoka, Fukuoka Pref, Japan (Recruiting)
• SOUSEIKAI Fukuoka Mirai Hospital — Fukuoka, Japan (Recruiting)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions Sepsis Associated Disseminated Intravascular Coagulation; Sepsis, Disseminated Intravascular Coagulation, Coagulopathy