Clinical trial NCT06637371: A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Asthma
Keywords: AMG 691
Pulmonology
Immunology
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 8 months
Secondary outcomes:
measure: Maximum Concentration (Cmax) of AMG 691
timeFrame: Up to approximately 8 months
measure: Area Under the Curve (AUC) of AMG 691
timeFrame: Up to approximately 8 months
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Aventura
country: United States
facility: Translational Clinical Research LLC
state: Florida
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Adelaide
country: Australia
facility: Clinical Medical and Analytical eXellence CMAX
state: South Australia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: