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Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy Volunteers

NCT05663593 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-12-23

No results posted yet for this study

Summary

This is a phase I, randomised, double-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HSK31858 in healthy volunteers

Conditions

  • Healthy Volunteers

Interventions

DRUG

HSK31858, tablet

Starting dose in single ascending dose: 5 mg

DRUG

Placebo, tablet

Matching placebo

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jie Hou · Peking University Care Luzhong Hospital

  • Hong Wang · Peking University Care Luzhong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2022-08-15
Completion
2022-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663593 on ClinicalTrials.gov