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A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

NCT05354336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-05-05

No results posted yet for this study

Summary

This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.

Conditions

  • Healthy Volunteers

Interventions

DRUG

SHR6390(100mg)

SHR6390 at a single oral dose of 100 mg.

DRUG

SHR6390(125mg)

SHR6390 at a single oral dose of 125 mg.

DRUG

SHR6390(150mg)

SHR6390 at a single oral dose of 150 mg.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2019-08-24
Completion
2019-08-24

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 NCT05354336 on ClinicalTrials.gov