Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1834845 · 4 trials · 5 indications
The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments
The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments. Erythema score will be measured by Antera 3D camera.
Part 1 in healthy male subject
Part 1 in healthy male subject
Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing
Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
Part 1 Cav:Average concentration within a dosing interval after multiple dosing
Part 2: Cav: Average concentration within a dosing interval after multiple dosing
in study part A
in study part A
in study part A
in study part A
in study part A
in study part B
in study part B
The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe
AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)
Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845
| Arm | Type | Description |
|---|---|---|
| BAY1834845 arm | EXPERIMENTAL | BAY1834845 will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| BAY1830839 arm | EXPERIMENTAL | BAY1830839 will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| Prednisolone arm | ACTIVE_COMPARATOR | Prednisolone will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| Placebo arm | PLACEBO_COMPARATOR | Placebo will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| BAY1834845 | EXPERIMENTAL | Part 1 in healthy male subjects: Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2) |
| Matching Placebo | PLACEBO_COMPARATOR | Part 1: Matching placebo in healthy male subjects. |
| Chosen dose of BAY1834845 | EXPERIMENTAL | Part 2: This dose level will be adminstered in female and male patients with psoriasis |
| Placebo | PLACEBO_COMPARATOR | Part 2: The placebo will be adminstered in female and male patients with psoriasis |
| Oral BAY1834845 | EXPERIMENTAL | Study Part A, cross over sequence: 1. single oral dose of BAY1834845 2. single oral dose of BAY1834845 + i.v. BAY1834845 3. single oral dose of BAY1834845 under fed conditions |
| Oral BAY1834845 + i.v. BAY1834845 | EXPERIMENTAL | Study Part A, cross over sequence: 1. single oral dose of BAY1834845+ i.v. BAY1834845 2. single oral dose of BAY1834845 3. single oral dose of BAY1834845 under fed conditions |
| Oral Methotrexate | EXPERIMENTAL | Study part B, cross over sequence: 1. single oral dose of methotrexate (MTX) 2. single oral dose of MTX + single oral dose of BAY1834845 |
| Oral Methotrexate + oral BAY1834845 | EXPERIMENTAL | Study part B, cross over sequence: 1. single oral dose of methotrexate (MTX) + single oral dose of BAY1834845 2. single oral dose of MTX |
| Dose escalation/BAY1834845 | EXPERIMENTAL | Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day |
| Name | Type | Description |
|---|---|---|
| BAY1834845 | DRUG | Tablet, oral. |
| BAY1830839 | DRUG | Tablet, oral. |
| Prednisolone | DRUG | Tablet, oral. |
| Placebo | DRUG | Tablet, oral. |
| Matching Placebo | OTHER | Orally administered. |
| Midazolam | DRUG | Part 1: Orally administered 1mg as a single dose. |
| Methotrexate | DRUG | Single dose of commercially available MTX |
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Overtly healthy as determined by medical evaluation including medical and surgical history, physical examination, laboratory tests, ECG and vital signs. * Participant has Fitzpa...
BAY1834845 is an investigational small molecule developed by Bayer AG for immune mediated inflammatory diseases. It has been studied in Phase 1 clinical trials in healthy volunteers and in patients with psoriasis, inflammation, and pelvic inflammatory disease. It is not an approved medicine and remains in clinical development.
BAY1834845 is being developed for immune mediated inflammatory diseases, including psoriasis, general inflammation, and pelvic inflammatory disease. All studies to date are Phase 1 trials, so the drug has no approved use. It is an investigational oral small molecule from Bayer AG.
BAY1834845 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 clinical program for the compound, including first in human, multiple dose, and drug interaction studies conducted in Germany and the Netherlands.
BAY1834845 is in Phase 1 clinical development. Four Phase 1 trials have been completed, including a first in human study, a multiple dose study in healthy male subjects and patients with psoriasis, and studies of oral pharmacokinetics and drug interactions. No later phase trials have been reported.
Completed Phase 1 trials of BAY1834845 include NCT03054402, a first in human study; NCT03493269, a multiple dose study in healthy male subjects and patients with psoriasis; NCT03244462, a food effect and pharmacokinetics study; and NCT05003089, a seven day twice daily dosing study in healthy male participants.
No. BAY1834845 is an investigational drug and has not been approved by the FDA. It has completed only Phase 1 clinical trials, which assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and patients with psoriasis. Further clinical development would be required before any regulatory approval.