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

Haisco Pharmaceutical Group

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: HSK47388; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06926218

HSK47388-101

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

HSK47388

Experimental group

Description:

Single oral doses of HSK47388

Treatment:

Drug: HSK47388

placebo

Experimental group

Description:

single oral dose of placebo

Treatment:

Drug: Placebo