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Not yet recruiting NCT06926218

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HSK47388, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

Interventions

  • Drug HSK47388
    cohort 1 to cohort 5
  • Drug Placebo
    cohort 1 to cohort 5

Primary outcome measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE [Time frame: 7 days after single dose]
Secondary outcome measures (5)
  • Cmax [Time frame: Predose up to Day 5 postdose]
  • Tmax [Time frame: Predose up to Day 5 postdose]
  • AUC [Time frame: Predose up to Day 5 postdose]
  • t1/2 [Time frame: Predose up to Day 5 postdose]
  • CL/F [Time frame: Predose up to Day 5 postdose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • CMAX Clinical Research — Adelaide

Identifiers

NCT: NCT06926218 · HSK47388-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗