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
Amgen
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 provi…
Interventions
- DrugAMG 691
Subcutaneous (SC) injection
- DrugPlacebo
SC injection
Locations (21)
- Orange County Research CenterLake Forest, California
- Translational Clinical Research LLCAventura, Florida
- Destiny Research CenterPalmetto Bay, Florida
- ClinCept, LLCColumbus, Georgia
- Chesapeake Clinical Research IncWhite Marsh, Maryland
- Brigham and Womens HospitalBoston, Massachusetts