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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Orange County Research Center
Lake Forest, California, United States
RECRUITINGNumber of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meet at least 1 of the following serious criteria: Immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. Includes AEs of interest (AEOI), and AEs leading to discontinuation.
Time frame: Up to approximately 11 months
Maximum Concentration (Cmax) of AMG 691
Time frame: Up to approximately 11 months
Area Under the Curve (AUC) of AMG 691
Time frame: Up to approximately 11 months
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