A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

Phase 1

Recruiting

• Conditions: Asthma
• Interventions: Drug: AMG 691; Drug: Placebo

• Registration Number: NCT06637371
• Lead Sponsor: Amgen

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Study Start: 2024-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-01-27
• Study Completion: 2026-06-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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 7 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: Im...

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of AMG 691	Up to approximately 7 months
Maximum Concentration (Cmax) of AMG 691	Up to approximately 7 months

Trial Locations

Locations (2)

Orange County Research Center; 🇺🇸 Lake Forest, California, United States

Translational Clinical Research LLC; 🇺🇸 Aventura, Florida, United States