A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SHR6390(100mg); Drug: SHR6390(125mg); Drug: SHR6390(150mg)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR6390（100mg）	Drug: SHR6390(100mg); SHR6390 at a single oral dose of 100 mg.
Experimental: SHR6390（125mg）	Drug: SHR6390(125mg); SHR6390 at a single oral dose of 125 mg.
Experimental: SHR6390（150mg）	Drug: SHR6390(150mg); SHR6390 at a single oral dose of 150 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	12 days
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
Area under the plasma concentration versus time curve (AUC)0-∞	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞	12 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): August 24, 2019
• Study Completion (Actual): August 24, 2019

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SHR6390-I-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No