This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
3. Able and willing to attend the necessary visits to the study site
Exclusion Criteria:
1. Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
3. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
Primary outcome measure(s)
Number of participants with treatment-related adverse events as assessed by CTCAE — 7 days after single dose The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters), physical examination findings, vital signs
Trial sites (1)
Facility
City
Region
Status
CMAX Clinical Research
Adelaide
Australia
More Haisco Pharmaceutical Group Co., Ltd. trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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