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Also known as Efavaleukin alfa
AMG 592 · 4 trials · 3 indications
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs.
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Group 1: Chinese participants - efavaleukin alfa dose level 1 | EXPERIMENTAL | Chinese participants will receive a single dose of efavaleukin alfa at dose level 1. |
| Group 2: Chinese participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Chinese participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Group 3: Japanese participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Japanese participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Group 4: Caucasian participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Caucasian participants will receive a single dose of efavaleukin alfa at dose level 2. |
| 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 |
| Efavaleukin Alfa | EXPERIMENTAL | Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W). |
| Placebo | PLACEBO_COMPARATOR | Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W). |
| 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. |
| Name | Type | Description |
|---|---|---|
| Efavaleukin alfa | DRUG | Administered as a single dose SC injection. |
| AMG 592 | DRUG | Administered as SC injection |
| Placebo | OTHER | Administered as SC injection |
Inclusion Criteria: * Healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening. * Chinese, Japanese, or Caucasian participant: * Chinese participants must be of Chinese ancestry (4 grandparents and biological parents). * Japanese participants mus...
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.