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

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: AMG 691

Study type: Interventional

Funder types: Industry

Identifiers

NCT06637371

20230151

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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124 participants in 3 patient groups

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

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

Treatment:

Drug: AMG 691

Drug: Placebo

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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

Treatment:

Drug: AMG 691

Drug: Placebo

Part C: Multiple Dose

Experimental group

Description:

Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.

Treatment:

Drug: AMG 691

Drug: Placebo