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Not yet recruiting Phase 1 NCT06926218

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

trial.available_in: БГ
Overview
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
Who can participate
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.
Locations 1
Australia (1)
CMAX Clinical Research
Adelaide
Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
01.05.2025
Completion date
01.09.2025
Registry ID
NCT06926218
Source
anzctr
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