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ACTIVE NOT RECRUITINGPhase1

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

Sponsor: Amgen

NCT ID: NCT06637371

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AMG 691 (drug), Placebo (drug)
How long the study runs
Study runs about 30 months (dates as stated)
About the drug or intervention
AMG 691 — drug: Subcutaneous (SC) injection · Placebo — drug: SC injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
21
Started
2024-10-16
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for asthma
  • • Phase1 - 21 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with asthma

Where?

  • • Cambridge - VPD Heart and Lung Research Institute
  • • London - Chelsea and Westminster Hospital
  • • Manchester - The Medicines Evaluation Unit

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Asthma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

Biomarkers mentioned

or positive

Treatment history

Treatments you must have had:

  • ✓ a Body Mass Index between 18
  • ✓ documentation of physician diagnosed asthma for ≥ 12 months
  • ✓ a pre-bronchodilator percent predicted FEV1 ≥ 50% at screening visit and Day -1
  • ✓ peripheral blood eosinophils ≥ 200 cells/μl at screening visit and Day -1

What the study is looking for

  • ✓Inclusion Part A and B
  • ✓Participants must be capable of giving agreement to take part and have provided agreement to take part.
  • ✓Participants must be 18 to 65, inclusive at time of signing of agreement to take part.
  • ✓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...
See the full 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.

Where Is This Study? (3 UK sites)

VPD Heart and Lung Research Institute

Cambridge CB2 0AY, United Kingdom

Chelsea and Westminster Hospital

London SW10 9NH, United Kingdom

Hospital R&D contact (matched)

Damon Foster

damon.foster2@nhs.net020 3316 6887

The Medicines Evaluation Unit

Manchester M23 9QZ, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-06