Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 357 · 1 trial · 1 indication
Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| AMG 357 | EXPERIMENTAL | AMG 357 is a small molecule for treatment of inflammatory disease |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to AMG 357 containing no active drug |
| Name | Type | Description |
|---|---|---|
| AMG 357 | DRUG | Oral administration available in varying dose strength. |
| Placebo | DRUG | Matching placebo to AMG 357 containing no active drug |
Inclusion Criteria: * Healthy Adult subjects between 25 and 55 years old * Body mass index (BMI) between 18 and 32 kg/m2 * Normal or clinically acceptable physical examination, clinical laboratory values, and ECG * Additional inclusion criteria apply Exclusion Criteria: * Any history or evidence ...
AMG 357 is an investigational small molecule being developed for the treatment of inflammatory disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and tolerability in humans.
AMG 357 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule in Phase 1 clinical development for inflammatory disease.
AMG 357 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of the drug in healthy subjects. It remains investigational and has not been approved.
AMG 357 has one completed clinical trial, registered as NCT01695876. This was a Phase 1, randomized, double-blind, placebo-controlled study conducted in New Zealand with 58 healthy subjects aged 25 years and older, evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.
No, AMG 357 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for inflammatory disease. The completed Phase 1 trial was designed to assess safety and tolerability in healthy volunteers, and further clinical development would be required before any regulatory approval.