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AMG 592 · 2 trials · 1 indication
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Arm 1: AMG 592 Dose 1 | EXPERIMENTAL | Participants will receive AMG 592 dose 1 subcutaneously |
| Arm 2: AMG 592 Dose 2 | EXPERIMENTAL | Participants will receive AMG 592 dose 2 subcutaneously |
| Arm 3: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo subcutaneously |
| AMG 592: Dose 1 | EXPERIMENTAL | Administered as a single dose subcutaneous (SC) injection. |
| AMG 592: Dose 2 | EXPERIMENTAL | Administered as a single dose SC injection. |
| AMG 592: Dose 3 | EXPERIMENTAL | Administered as a single dose SC injection. |
| AMG 592: Dose 4 | EXPERIMENTAL | Administered as a single dose SC injection. |
| AMG 592: Dose 5 | EXPERIMENTAL | Administered as a single dose SC injection. |
| AMG 592: Dose 6 | EXPERIMENTAL | Administered as a single dose SC injection. |
| AMG 592: Dose 7 | EXPERIMENTAL | Administered as a single dose SC injection. |
| AMG 592: Dose 8 | EXPERIMENTAL | Administered as a single dose SC injection. |
| Placebo | PLACEBO_COMPARATOR | Administered as SC injection. |
| Name | Type | Description |
|---|---|---|
| AMG 592 | DRUG | Administered as SC injection |
| Placebo | OTHER | Administered as SC injection |
Inclusion Criteria: * Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage) * Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m\^2 at the time of scree...
AMG 592 is an investigational small molecule being developed for chronic Graft-versus-Host Disease (cGVHD), a condition that can occur after stem cell or bone marrow transplants. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AMG 592 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical trials for chronic Graft-versus-Host Disease (cGVHD).
AMG 592 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two Phase 1 trials have been completed, both involving healthy participants, to evaluate the drug's safety and pharmacokinetics.
AMG 592 has completed two Phase 1 clinical trials. NCT05873907 enrolled 64 healthy participants in the United States to evaluate safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics. NCT05885451 enrolled 18 healthy Japanese participants in Australia to assess pharmacokinetics, safety, and tolerability.
Yes, both completed Phase 1 trials of AMG 592 enrolled healthy volunteers. The first trial (NCT05873907) included 64 healthy participants in the United States, and the second (NCT05885451) included 18 healthy Japanese participants in Australia. These studies focused on safety and pharmacokinetics.