A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: SHR6390(100mg); Drug: SHR6390(125mg); Drug: SHR6390(150mg)

• Registration Number: NCT05354336
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-13
• Primary Completion: 2019-08-24
• Study Completion: 2019-08-24
• Status Verified: 2022-04
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR6390（100mg）	SHR6390(100mg)	-
SHR6390（125mg）	SHR6390(125mg)	-
SHR6390（150mg）	SHR6390(150mg)	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)0-t	12 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Peak Plasma Concentration (Cmax)	12 days	Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-∞	12 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

Secondary Outcome Measures

Name	Time	Method
Incidence of abnormal blood pressure	22 days	Monitor both systolic and diastolic blood pressure
Incidence of Treatment-Emergent Adverse Events	22 days	Collection of adverse events
Incidence of abnormal temperature	22 days	Monitor the temperature
Incidence of abnormal electrocardiogram waveform	22 days	Electrocardiogram inspection

Trial Locations

Locations (1)

Phase I Clinical Research Center; 🇨🇳 Qingdao, Shandong, China