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A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers

NCT05023525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-09-06

No results posted yet for this study

Summary

This is a Phase I, single-dose escalation clinical trial for HSK31858 conducted in healthy volunteers. The safety, tolerability, and pharmacokinetics of HSK31858 tablet in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

Conditions

  • Healthy

Interventions

DRUG

HSK31858, tablet

Starting dose in single ascending dose: 5 mg

DRUG

Placebo, tablet

Matching placebo

Sponsors & Collaborators

  • Haisco Pharmaceutical(Australia) Pty Ltd.

    collaborator UNKNOWN

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ofer Gonen · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2022-04-19
Completion
2022-08-16

Countries

  • Australia

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 NCT05023525 on ClinicalTrials.gov