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

Launched by AMGEN · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called AMG 691 to see how safe it is for people, including those with mild-to-moderate asthma. The study involves healthy volunteers and individuals with asthma to understand how the medication works and how well it can be tolerated when given in single and multiple doses. The trial is currently looking for participants aged 18 to 65 who are healthy or have a documented history of asthma.

To be eligible for the study, volunteers must be able to provide informed consent, meaning they understand the trial and agree to participate. Healthy participants will be screened to ensure they are in good health, while those with asthma must have been diagnosed for at least a year and meet specific breathing test requirements. Participants can expect to receive either the study medication or a placebo (a sugar pill) during the trial, and they'll be closely monitored for any side effects. It's important to note that certain health conditions could exclude someone from participating, such as a history of severe allergies or recent serious infections. If you're interested in learning more about participating, please reach out to the study team for additional information.

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Eligibility criteria

• • 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/m2 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 65 inclusive at time of signing of informed consent.
• • 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) ≥ 12% and ≥200 mL in the 12 months before screening or at the screening visit.
• • Participants must have a pre-bronchodilator percent predicted FEV1 between 55 and 85% inclusive at screening visit and Day -1.
• • Participants must have peripheral blood eosinophils ≥ 300 /ul at screening visit and Day -1
• • Participants must have a fractional exhaled nitric oxide (FeNO) ≥ 30 ppb at screening visit and Day -1.
• • Participant must not use inhaled corticosteroids (ICS) or must be treated with low-dose or medium-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 requiring admission to intensive care unit.