To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in Chinese healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Percentage of participants with at least one safety event
Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, electrocardiogram (ECG) evaluations, clinical laboratory assessments, and physical examination findings. Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) will be captured.
Time frame: baseline up to Day 9
Pharmacokinetics -maximum plasma concentration (Cmax)
Determination of maximum plasma concentration (Cmax)
Time frame: baseline up to Day 8
Pharmacokinetics - time to maximum concentration (Tmax)
Determination of time to maximum concentration
Time frame: baseline up to Day 8
Pharmacokinetics - plasma exposure (AUC0-t, AUC0-inf)
Determination of plasma exposure (AUC0-t, AUC0-inf)
Time frame: baseline up to Day 8
Pharmacokinetics - terminal elimination half life (t1/2)
Determination of terminal half life
Time frame: baseline up to Day 8
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