Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06926218

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

HSK47388

Drug

cohort 1 to cohort 5

Placebo

Drug

cohort 1 to cohort 5

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE

    Time frame: 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

Secondary outcomes

  1. Cmax

    Time frame: Predose up to Day 5 postdose

    Maximum concentration

  2. Tmax

    Time frame: Predose up to Day 5 postdose

    Time to maximum concentration

  3. AUC

    Time frame: Predose up to Day 5 postdose

    Area under the drug concentrationtime curve

  4. t1/2

    Time frame: Predose up to Day 5 postdose

    Apparent terminal half-life

  5. CL/F

    Time frame: Predose up to Day 5 postdose

    Apparent total plasma clearance of drug

Study contacts

Contact information is provided by the study sponsor or research team.

Redzepagic Emir

CONTACT

[email protected]

0413231264

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HSK47388 in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.