This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new medication called HSK47388 in healthy adults. The researchers want to find out how safe the medication is, how well it is tolerated, and how the body processes it. This study will take place at a single location and will involve healthy volunteers aged 18 to 55 years. Participants will be randomly assigned to receive either the medication or a placebo (a sugar pill that looks like the medication but has no active ingredients) without knowing which one they are getting.

To participate, individuals must be able to understand the study's goals and potential risks, and they need to be willing and able to attend all required visits. However, those with certain health conditions, such as serious diseases affecting the nervous system, heart, or other major systems, will not be eligible. Throughout the trial, participants can expect close monitoring to ensure their safety and to gather important information about how HSK47388 works in the body. This study is not yet recruiting, but it represents an important step in understanding this new medication's effects.

Gender

ALL

Eligibility criteria

• 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.