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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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06637371
Enrollment
21
Registered
2024-10-15
Start date
2024-10-16
Completion date
2027-04-10
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

AMG 691, Pulmonology, Immunology

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.

Interventions

Subcutaneous (SC) injection

DRUGPlacebo

SC injection

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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/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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Up to approximately 11 monthsAn 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.

Secondary

MeasureTime frame
Maximum Concentration (Cmax) of AMG 691Up to approximately 11 months
Area Under the Curve (AUC) of AMG 691Up to approximately 11 months

Countries

Australia, Belgium, Canada, United Kingdom, United States

Contacts

STUDY_DIRECTORMD

Amgen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026