Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1830839 · 1 trial · 1 indication
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
maximum observed drug concentration in plasma after single dose administration
| Arm | Type | Description |
|---|---|---|
| BAY1830839 | EXPERIMENTAL | Single Dose escalations |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| BAY1830839 | DRUG | Dose escalation in healthy male subjects |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Body mass index (BMI) : ≥18.5 and ≤30 kg/m\*2 Exclusion Criteria: * Relevant diseases within the last 4 weeks prior to the first study drug administration * Febrile illness within 4 weeks before the first study drug administration * Known hypersensitivity to the study drugs ...
BAY1830839 is an investigational small molecule developed by Bayer AG for rheumatoid arthritis. It has been studied in a Phase 1 first-in-man trial in healthy male volunteers. It is not an approved medicine and remains in early clinical development.
BAY1830839 is being developed for rheumatoid arthritis, an inflammatory joint disease. The only reported human study enrolled healthy male volunteers rather than patients with rheumatoid arthritis, so its use in patients has not been established. It is investigational and not approved for any indication.
BAY1830839 is developed by Bayer AG, the German pharmaceutical and life sciences company. Bayer's ordinary shares trade on the Frankfurt Stock Exchange, and its American Depositary Receipts trade over the counter in the United States under the ticker BAYRY.
BAY1830839 is in Phase 1 development. One Phase 1 trial has been conducted and is completed, with 64 participants enrolled. The study was randomized, double-blind, and placebo-controlled. The drug is investigational and has not been approved by the FDA or any other regulator.
BAY1830839 has been studied in one clinical trial, NCT03540615, titled a first-in-man, single dose escalation study of safety, tolerability, and pharmacokinetics. The Phase 1 trial enrolled 64 healthy male volunteers aged 18 years and older in Germany and is completed.
Yes. The Phase 1 trial NCT03540615 for BAY1830839 enrolled healthy volunteers rather than rheumatoid arthritis patients. It was a randomized, double-blind, placebo-controlled single dose escalation study of 64 male participants in Germany, assessing safety, tolerability, and pharmacokinetics.