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AMG 691 · 2 trials · 2 indications
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meet at least 1 of the following serious criteria: Immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. Includes AEs of interest (AEOI), and AEs leading to discontinuation.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC) |
| Cohort 2 | EXPERIMENTAL | Japanese participants will receive AMG 691 at the Level A dose administered SC |
| Cohort 3 | EXPERIMENTAL | Chinese participants will receive AMG 691 at the Level B dose administered SC |
| Cohort 4 | EXPERIMENTAL | Japanese participants will receive AMG 691 at the Level B dose administered SC |
| Part A: Single Ascending Dose (SAD) | EXPERIMENTAL | Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. |
| Part B: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. |
| Part C: Multiple Dose | EXPERIMENTAL | Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo. |
| Name | Type | Description |
|---|---|---|
| AMG 691 | DRUG | AMG 691 will be administered subcutaneously |
| Placebo | DRUG | SC injection |
Inclusion Criteria: * Healthy male or female participants, 18 to 60 years of age. * First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Jap...
AMG 691 is an investigational small molecule being developed by Amgen Inc. for the treatment of asthma. It is currently being studied in Phase 1 clinical trials in healthy participants and in participants with mild-to-moderate asthma. The drug is not yet approved and remains in early clinical development.
AMG 691 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting Phase 1 clinical trials to evaluate the safety and tolerability of AMG 691 in healthy participants and in participants with asthma.
AMG 691 is in Phase 1 clinical development. It is being evaluated in two early-stage trials: one in healthy participants and participants with mild-to-moderate asthma, and another in healthy Chinese and Japanese volunteers. The drug is investigational and has not been approved by regulatory authorities.
AMG 691 is being studied in two Phase 1 trials. NCT06637371 is a randomized, double-blind, placebo-controlled study in healthy participants and participants with mild-to-moderate asthma, conducted in the United States, Australia, Belgium, Canada, and the United Kingdom. NCT07745907 is a trial in healthy Chinese and Japanese volunteers, conducted in the United States.
AMG 691 is the only name provided for this investigational drug. No alternative names have been reported. It is a small molecule being developed by Amgen Inc. for respiratory conditions, specifically asthma, and is currently in Phase 1 clinical trials.