This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner Part 2: Two single oral doses of ASC10 will be administered to participants, in an open-label manner
Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
Time frame: From screening through study completion, up to 12 days
Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD
Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate.
Time frame: From screening through study completion, up to 12 days
Part1: Number of Participants With Laboratory Abnormalities in MAD
Time frame: From screening through study completion, up to 12 days
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