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

NCT06926218 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HSK47388-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 of HSK47388

Conditions

Healthy

Keywords

HSK47388, Phase I

Outcome Measures

Primary Outcomes (1)

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

  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

  7 days after single dose

Secondary Outcomes (5)

• Cmax

  Predose up to Day 5 postdose

• Tmax

  Predose up to Day 5 postdose

• AUC

  Predose up to Day 5 postdose

• t1/2

  Predose up to Day 5 postdose

• CL/F

  Predose up to Day 5 postdose

Study Arms (2)

HSK47388

EXPERIMENTAL

Single oral doses of HSK47388

Drug: HSK47388

placebo

EXPERIMENTAL

single oral dose of placebo

Drug: Placebo

Interventions

HSK47388 DRUG

cohort 1 to cohort 5

HSK47388

Placebo DRUG

cohort 1 to cohort 5

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, Australia

Location

Central Study Contacts

Redzepagic Emir

CONTACT

0413231264; Emir.Redzepagic@cmax.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)