A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects

NCT ID: NCT04862884

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2021-09-24

Brief Summary

The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HRS4800 tablets

Group Type: EXPERIMENTAL

HRS4800 tablets

Intervention Type: DRUG

1. Drug: HRS4800 tablets Low-dose group, single oral administration

2. Drug: HRS4800 tablets Low-medium dose group, single oral administration

3. Drug: HRS4800 tablets medium -dose group, single oral administration

4. Drug: HRS4800 tablets Medium and high dose group, single oral administration

5. Drug: HRS4800 tablets High-dose group, single oral administration

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

1. Drug: placebo Low-dose group, single oral administration

2. Drug: placebo Low-medium dose group, single oral administration

3. Drug: placebo medium -dose group, single oral administration

4. Drug: placebo Medium and high dose group, single oral administration

5. Drug: placebo High-dose group, single oral administration

Interventions

HRS4800 tablets

1. Drug: HRS4800 tablets Low-dose group, single oral administration

2. Drug: HRS4800 tablets Low-medium dose group, single oral administration

3. Drug: HRS4800 tablets medium -dose group, single oral administration

4. Drug: HRS4800 tablets Medium and high dose group, single oral administration

5. Drug: HRS4800 tablets High-dose group, single oral administration

Intervention Type: DRUG

placebo

1. Drug: placebo Low-dose group, single oral administration

2. Drug: placebo Low-medium dose group, single oral administration

3. Drug: placebo medium -dose group, single oral administration

4. Drug: placebo Medium and high dose group, single oral administration

5. Drug: placebo High-dose group, single oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.

2. Male aged between 18 years and 55 years at screening, inclusive.

3. Total body weight ≥50 kg at screening, and body mass index (BMI) between 19.0 and 26.0 kg/m2, inclusive.

4. Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.

5. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator.

Exclusion Criteria

1. History of severe digestive system disease or having a digestive disease currently within 3 months of screening or before first dosing, and may affect drug absorption or have safety risks.

2. Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.

3. ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.

4. Subject's supine systolic BP is ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg at screening or before first dosing.

5. Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.

6. Positive drug screening tests,.

7. Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or received blood within 2 months prior to dosing.

8. History of allergy to the study drug or any component of it.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

li Yue

Role: CONTACT

li.yue@hengrui.com

86-021-61623632

Miaoyan Chen

Role: CONTACT

Miaoyan.chen@hengrui.com

86- 021-61623632

Other Identifiers

HRS4800-101

Identifier Type: -

Identifier Source: org_study_id