A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

NCT05354336 | Completed Phase 1

• 1 other identifier: SHR6390-I-105
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  22 days

• Incidence of abnormal blood pressure

  22 days

• Incidence of abnormal temperature

  22 days

• Incidence of abnormal electrocardiogram waveform

  22 days

Study Arms (3)

SHR6390（100mg）

EXPERIMENTAL

Drug: SHR6390(100mg)

SHR6390（125mg）

EXPERIMENTAL

Drug: SHR6390(125mg)

SHR6390（150mg）

EXPERIMENTAL

Drug: SHR6390(150mg)

Interventions

SHR6390(100mg) DRUG

SHR6390 at a single oral dose of 100 mg.

SHR6390（100mg）

SHR6390(125mg) DRUG

SHR6390 at a single oral dose of 125 mg.

SHR6390（125mg）

SHR6390(150mg) DRUG

SHR6390 at a single oral dose of 150 mg.

SHR6390（150mg）

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: half male and half female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: June 13, 2019
• Primary Completion: August 24, 2019
• Study Completion: August 24, 2019
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)