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BAY 3389934 · 2 trials · 3 indications
Investigate the safety and tolerability of BAY 3389934 15 mg/h and a second, higher dose (will be determined based on the result of 15 mg/h dose step), 4-hours infusion, respectively.
| Arm | Type | Description |
|---|---|---|
| Dose Step 1 BAY 3389934 | EXPERIMENTAL | 15 mg/h/ intravenous Single Dose for 4 h fasting |
| Dose Step 2 BAY 3389934 | EXPERIMENTAL | Max. dose 35 mg / h / intravenous - actual dose will be determined after Dose Step 1 Single Dose for 4 h fasting |
| Dose Step 1 and Dose Step 2 Placebo | PLACEBO_COMPARATOR | Placebo / intravenous Single Dose for 4 h Fasting |
| Cohort 1 of BAY3389934 | EXPERIMENTAL | Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. |
| Cohort 2 of BAY3389934 | EXPERIMENTAL | Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. |
| Name | Type | Description |
|---|---|---|
| BAY 3389934 | DRUG | Solution for intravenous infusion |
| Matching Placebo / Diluent | DRUG | Solution for intravenous infusion |
| BAY3389934 | DRUG | Solution for IV infusion |
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 ...
Top 3 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Bayer | BAYRY | 2 | PHASE1 | BAY 3389934 |
BAY 3389934 is an investigational small molecule developed by Bayer AG for sepsis and sepsis associated disseminated intravascular coagulation (DIC). It is in Phase 1 clinical development and has not been approved. The program includes a completed Phase 1 study in healthy Japanese volunteers and a recruiting Phase 1 study in patients with sepsis induced coagulopathy.
BAY 3389934 is being studied for sepsis and sepsis associated disseminated intravascular coagulation (DIC), conditions in which abnormal blood clotting accompanies severe infection. It remains investigational and is not approved for any use. Clinical testing so far has focused on safety, tolerability, and dose selection rather than confirmed efficacy.
Bayer AG develops BAY 3389934. Bayer trades on the OTC market under the ticker BAYRY. The company is running the Phase 1 program for this small molecule in sepsis and sepsis associated disseminated intravascular coagulation (DIC), with studies conducted in Japan, the United States, Belgium, France, Germany, and the Netherlands.
BAY 3389934 is in Phase 1 clinical development. One Phase 1 trial has been completed and one Phase 1 trial is currently recruiting. The drug is investigational and has not received FDA approval. The completed study enrolled 16 healthy Japanese volunteers, and the recruiting study plans to enroll 36 participants.
BAY 3389934 has two Phase 1 trials. NCT07176728, completed, assessed safety and dose effects in 16 healthy Japanese volunteers and enrolled in Japan. NCT06854640 is recruiting 36 adults with sepsis induced coagulopathy across the United States, Belgium, France, Germany, and the Netherlands. Both trials require participants aged 18 years or older.
Yes, BAY 3389934 and BAY3389934 refer to the same investigational compound from Bayer AG. The spelling without a space is a common alternate form used in study records and search queries. Both names identify the same Phase 1 small molecule being studied in sepsis and sepsis associated disseminated intravascular coagulation (DIC).