A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Parti… (NCT06637371) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
United States, Australia, Belgium21 participantsStarted 2024-10-16
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since AMG 691 is in Phase 1, which means it's being tested in humans for the first time, what is actually known so far about whether it's safe, and how does that uncertainty compare to the asthma treatments I'm already on or could start?
2The main thing this trial is measuring is how many people experience side effects — not whether the drug works better than existing treatments — so is my asthma currently well-controlled enough that joining a safety-focused study like this makes sense for me right now?
3The trial is no longer actively recruiting, so is there any possibility of me still being considered for enrollment, or should I be focusing my energy on other treatment options instead?
4Since this study includes both healthy participants and people with mild-to-moderate asthma, can you help me understand where my specific asthma severity falls, and whether that would have even made me a candidate for this trial?
5Given that this is a placebo-controlled study, meaning I could receive a dummy treatment instead of AMG 691, how would my asthma be managed during the trial period if my symptoms worsened?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)