A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Open-Label, Phase I Clinical Study on SHR6390 of Different Specifications After Process Modification in Healthy Chinese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05354336
• Other study ID #: SHR6390-I-105
• Status: Completed
• Phase: Phase 1
• Start date: June 13, 2019
• Est. completion date: August 24, 2019

Study information

• Verified date: April 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 24, 2019
• Est. primary completion date: August 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SHR6390(100mg)
SHR6390 at a single oral dose of 100 mg.
• SHR6390(125mg)
SHR6390 at a single oral dose of 125 mg.
• SHR6390(150mg)
SHR6390 at a single oral dose of 150 mg.

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	12 days
Primary	Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	12 days
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	12 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	22 days
Secondary	Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	22 days
Secondary	Incidence of abnormal temperature	Monitor the temperature	22 days
Secondary	Incidence of abnormal electrocardiogram waveform	Electrocardiogram inspection	22 days