A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
- Registration Number
- 2025-520503-27-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy participants and participants with mild-to-moderate asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Single Ascending Dose (SAD) AMG 691 Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. Part A: Single Ascending Dose (SAD) Placebo Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. Part B: Multiple Ascending Dose (MAD) AMG 691 Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. Part B: Multiple Ascending Dose (MAD) Placebo Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. Part C: Multiple Dose AMG 691 Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo. Part C: Multiple Dose Placebo Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately 8 months 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.
- Secondary Outcome Measures
Name Time Method Maximum Concentration (Cmax) of AMG 691 Up to approximately 8 months Area Under the Curve (AUC) of AMG 691 Up to approximately 8 months
Trial Locations
- Locations (1)
Emmaues
🇧🇪Mechelen, Belgium