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Monoclonal Antibodies
AMG 691 for Asthma
Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Participants must be 18 to 65 inclusive at time of signing of informed consent.
* Female participants must be of non-childbearing potential.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 months
Summary
This trial aims to test the safety and how well participants can tolerate a new drug called AMG 691. The study will involve giving single doses of the drug to healthy participants and both single and multiple
Who is the study for?
This trial is for healthy adults and those with mild-to-moderate asthma, aged 18-65. Women must not be able to bear children. Asthma patients need a specific lung function score and blood eosinophil count, plus documented responsiveness to bronchodilators.
What is being tested?
The study tests AMG 691's safety in single (healthy participants) and multiple doses (both groups). Participants are randomly assigned to receive either the real drug or a placebo without knowing which one they're getting.
What are the potential side effects?
While the side effects of AMG 691 aren't listed here, common reactions may include irritation at the injection site, allergic reactions, headache, respiratory symptoms worsening temporarily after dosing, or other immune-related responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I am a woman who cannot become pregnant.
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I have been diagnosed with asthma by a doctor for at least 12 months.
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My lung function improved by at least 12% and 200 mL after using a bronchodilator.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part C: Multiple DoseExperimental Treatment2 Interventions
Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.
Group II: Part B: Multiple Ascending Dose (MAD)Experimental Treatment2 Interventions
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
Group III: Part A: Single Ascending Dose (SAD)Experimental Treatment2 Interventions
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,372 Total Patients Enrolled
25 Trials studying Asthma
6,549 Patients Enrolled for Asthma
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
945,116 Total Patients Enrolled
10 Trials studying Asthma
1,986 Patients Enrolled for Asthma