Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 691 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | Subcutaneous (SC) injection |
| Placebo | DRUG | SC injection |
Inclusion Part A and B * Participants must be capable of giving informed consent and have provided informed consent. * Participants must be 18 to 65, inclusive at time of signing of informed consent. * Participants must have a Body Mass Index between 18.0 to 30 kg/m\^2 and total body weight ≥ 40 kg...