A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

NCT ID: NCT05354336

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2019-08-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR6390（100mg）

Group Type: EXPERIMENTAL

SHR6390(100mg)

Intervention Type: DRUG

SHR6390 at a single oral dose of 100 mg.

SHR6390（125mg）

Group Type: EXPERIMENTAL

SHR6390(125mg)

Intervention Type: DRUG

SHR6390 at a single oral dose of 125 mg.

SHR6390（150mg）

Group Type: EXPERIMENTAL

SHR6390(150mg)

Intervention Type: DRUG

SHR6390 at a single oral dose of 150 mg.

Interventions

SHR6390(100mg)

SHR6390 at a single oral dose of 100 mg.

Intervention Type: DRUG

SHR6390(125mg)

SHR6390 at a single oral dose of 125 mg.

Intervention Type: DRUG

SHR6390(150mg)

SHR6390 at a single oral dose of 150 mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study.
• Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease.
• No pregnancy plan during the trial or within 6 months after completion of the trial.
• Voluntarily signed the informed consent form and strictly adherence to the study protocol.

Exclusion Criteria

• vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance.
• Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive;
• Any history of allergy, alcohol and drug abuse;
• blood donation, massive blood loss (≥400mL).
• Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening;
• use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening;
• use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening;
• A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phase I Clinical Research Center

Qingdao, Shandong, China

Countries

China

Other Identifiers

SHR6390-I-105

Identifier Type: -

Identifier Source: org_study_id