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

NCT06637371 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20230151
• Study Type: interventional
• Target: 124
• Locations: 5 countries
• Sites: 21

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.

Conditions

Asthma

Keywords

AMG 691; Pulmonology; Immunology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Concentration (Cmax) of AMG 691

  Up to approximately 11 months

• Area Under the Curve (AUC) of AMG 691

  Up to approximately 11 months

Study Arms (3)

Part A: Single Ascending Dose (SAD)

EXPERIMENTAL

Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.

Drug: AMG 691; Drug: 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.

Drug: AMG 691; Drug: 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.

Drug: AMG 691; Drug: Placebo

Interventions

AMG 691 DRUG

Subcutaneous (SC) injection

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD); Part C: Multiple Dose

Placebo DRUG

SC injection

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD); Part C: Multiple Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Study Sites (21)

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Translational Clinical Research LLC

Aventura, Florida, 33180, United States

RECRUITING

Destiny Research Center

Palmetto Bay, Florida, 33157, United States

RECRUITING

ClinCept, LLC

Columbus, Georgia, 31904, United States

COMPLETED

Chesapeake Clinical Research Inc

White Marsh, Maryland, 21162, United States

RECRUITING

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mayflower Clinical

South Dartmouth, Massachusetts, 02747, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

RECRUITING

University of North Carolina Clinical and Translational Research Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

RECRUITING

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Monroe Biomedical Research

North Charleston, South Carolina, 29406, United States

RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

TERMINATED

Clinical Medical and Analytical eXellence CMAX

Adelaide, South Australia, 5000, Australia

RECRUITING

Algemeen Ziekenhuis Sint Maarten-Emmaus vzw

Mechelen, 2800, Belgium

RECRUITING

Winchester District Memorial Hospital

Winchester, Ontario, K0C 2K0, Canada

RECRUITING

VPD Heart and Lung Research Institute

Cambridge, CB2 0AY, United Kingdom

RECRUITING

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

RECRUITING

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): June 7, 2027
• Study Completion (Estimated): June 7, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (15); AU (1); GB (3); BE (1); CA (1)