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
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.
• 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/m2 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.
• 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 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) ≥ 12% and ≥200 mL in the 12 months before screening or at the screening visit.
• Participants must have a pre-bronchodilator percent predicted FEV1 between 55 and 85% inclusive at screening visit and Day -1.
• Participants must have peripheral blood eosinophils ≥ 300 /ul at screening visit and Day -1
• Participants must have a fractional exhaled nitric oxide (FeNO) ≥ 30 ppb at screening visit and Day -1.
• Participant must not use inhaled corticosteroids (ICS) or must be treated with low-dose or medium-dose ICS and on a stable dose for a minimum of 12 weeks prior to screening.