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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Integrated Single Ascending Dose, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: AMG 691

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Clinical Medical and Analytical eXellence CMAX
• Belgium
  • Mechelen, Belgium, 2800
    • Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
• Canada
  • Ontario
    • Winchester, Ontario, Canada, K0C 2K0
      • Winchester District Memorial Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • VPD Heart and Lung Research Institute
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital
  • Manchester, United Kingdom, M23 9QZ
    • The Medicines Evaluation Unit
• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
  • Florida
    • Aventura, Florida, United States, 33180
      • Translational Clinical Research LLC
    • Palmetto Bay, Florida, United States, 33157
      • Destiny Research Center
  • Georgia
    • Columbus, Georgia, United States, 31904
      • ClinCept, LLC
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
    • South Dartmouth, Massachusetts, United States, 02747
      • Mayflower Clinical
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research LLC dba Nucleus Network
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Clinical and Translational Research Center
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy Asthma and Clinical Research Center
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Monroe Biomedical Research
  • Texas
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 at screening.
• Participants must be overtly healthy as determined by the investigator based on medical evaluation and study screening procedures.
• Female participants must be of non-childbearing potential.

Inclusion Part C

• Participants must be capable of giving informed consent and have provided informed consent.
• Participants must be 18 to 70, inclusive at time of signing of informed consent.
• Body mass index between 18.0 to 35 kg/m^2 and total body weight ≥ 40 kg at screening.
• Participants must have documentation of physician diagnosed asthma for ≥ 12 months prior to screening.
• Participants must have documented bronchodilator responsiveness of forced expiratory volume in 1 second (FEV1) ≥ 10% in the 10 years before screening or at the screening visit.
• Participants must have a pre-bronchodilator percent predicted FEV1 ≥ 50% at screening visit and Day -1. For participants on high-dose ICS, participants must have a percent-predicted FEV1 ≥ 70% at screening visit and on day -1.
• Participants must have peripheral blood eosinophils ≥ 200 cells/μl at screening visit and Day -1.
• Participants must have a fractional exhaled nitric oxide (FeNO) ≥ 25 ppb at screening visit and Day -1.
• Participant must not use inhaled corticosteroids (ICS) or must be treated with low-dose, medium-dose, or high-dose ICS and on a stable dose for a minimum of 12 weeks prior to screening.

Exclusion (applicable to all study parts)

• History of malignancy (except for in situ cervical cancer or surgically excised non-melanoma skin cancer occurring more than 5 years prior to randomization).
• History of anaphylaxis or hypersensitivity to biologic therapy or sensitivity to mammalian derived products.
• History of immunodeficiency or history of severe infection within the last 3 years requiring IV antibiotics.
• History of tuberculosis (TB), TB symptoms, or positive interferon gamma release assay.
• History of untreated or unresolved helminthic infection within 24 weeks of day 1.
• Positive human immunodeficiency virus (HIV) antibodies, hepatitis B core antigen, hepatitis B core antibody, or hepatitis C virus (HCV) ribonucleic acid (RNA).
• Male participants unwilling to follow contraceptive requirements.

Additional Exclusion for Part C only

• Female of childbearing potential not willing to use 2 methods of contraception with one being a highly effective method of contraception.
• History of pulmonary disease that may interfere with interpretation of study results.
• History of upper respiratory infection within 6 weeks of screening.
• Asthma Control Questionnaire (ACQ-6) > 3.
• Asthma symptoms or exacerbations requiring 2 or more systemic corticosteroid bursts (≥10 mg/day prednisone or equivalent for ≥ 3 days each) in the previous 12 months.
• More than one hospitalization or emergency department visit in the last year.
• History of life-threatening asthma exacerbation after the 12 years age requiring admission to intensive care unit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Single Ascending Dose (SAD); Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.	Drug: Placebo; SC injection; Drug: AMG 691; Subcutaneous (SC) injection
Experimental: Part B: Multiple Ascending Dose (MAD); Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.	Drug: Placebo; SC injection; Drug: AMG 691; Subcutaneous (SC) injection
Experimental: Part C: Multiple Dose; Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.	Drug: Placebo; SC injection; Drug: AMG 691; Subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	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.	Up to approximately 11 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Concentration (Cmax) of AMG 691	Up to approximately 11 months
Area Under the Curve (AUC) of AMG 691	Up to approximately 11 months

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2027

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Immunology; Pulmonology; AMG 691
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 20230151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No