Food Effect Study of HSK47388 in Healthy Subjects

NCT07192692 | Completed Phase 1

• 1 other identifier: HSK47388-104
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open-label, randomized, three-period crossover trial study to evaluate the effect of food and dosing and meal timing intervals on the pharmacokinetics (PK) of HSK46575 in healthy adult participants ,with an exploratory assessment of excretion pathways and excretion rates. Safety and tolerability will also be evaluated.

Conditions

Pharmaceutical Preparations; Health Adult Subjects

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

  5 days after every period dose

Secondary Outcomes (3)

• pharmacokinetics of HSK47388

  time after 5 days in each period

• pharmacokinetics of HSK47388

  time after 5 days in each period

• culmulative excretion rate

  5 days after dose in each period

Study Arms (3)

fast

EXPERIMENTAL

fast state

Dietary Supplement: fast

low fat meal

EXPERIMENTAL

take HSK47388 with low fat meal

Dietary Supplement: low fat meal

take meal after HSK47388 administration

EXPERIMENTAL

take meal after HSK47388 administration at specific time

Dietary Supplement: take meal after HSK47388 administration

Interventions

fast DIETARY_SUPPLEMENT

fast state

fast

low fat meal DIETARY_SUPPLEMENT

take HSK47388 with low fat meal

low fat meal

take meal after HSK47388 administration DIETARY_SUPPLEMENT

take meal after HSK47388 administration at specific time

take meal after HSK47388 administration

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)

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 25, 2025
• Study Start: August 8, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 28, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-08

Locations

CN (1)