A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Parti… (NCT06637371) | Clinical Trial Compass
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 States124 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 range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)