Status:
NOT_YET_RECRUITING
This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
- Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
- Able and willing to attend the necessary visits to the study site
Exclusion
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06926218
Start Date
May 1 2025
End Date
September 1 2025
Last Update
April 13 2025
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, Australia