This will be a Phase I, randomized, double-blind, positive- and placebo-controlled study to evaluate the safety, tolerability, and PK/PD of multiple oral doses of H008 in healthy adult subjects. Two dose levels of H008 at 20 mg and 40 mg will be studied in two sequential cohorts. Each cohort will be enrolled with 12 subjects (8 on H008, 2 on placebo and 2 on positive control drug). Subjects are only allowed to participate in one of the two cohorts. Both the investigational product and placebo will be given in a double blinded manner, while the positive control drug will be given in an open-label manner.Dose escalation to the next cohort will be permitted only when safety data until follow-up and PK data until 48 hours post-last dose, from all subjects in previous cohorts are reviewed, and the investigational product is deemed well tolerated. The study will consist of a screening period, a baseline period, a 7-day repeated-dose period and a safety follow-up period.
Age range
18 Years – 55 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The number and incidence of AEs in HVs of multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Up to final follow-up (Day16) or early termination.
The number and incidence of subjects with clinically significant changes of physical examinations (Safety and Tolerability)
Timeframe: Baseline up to Day 16
The number and incidence of subjects with abnormal vital signs of multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Baseline up to Day 16
The number and incidence of subjects with clinical defined abnormal laboratory tests of multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Baseline up to Day 16
The number and incidence of subjects with clinical defined abnormal of 12-lead ECG multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Baseline up to Day 16