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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Pain

Treatments: Drug: HRS4800 tablets; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04862884

HRS4800-101

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

HRS4800 tablets

Experimental group

Treatment:

Drug: HRS4800 tablets

placebo

Placebo Comparator group

Treatment:

Drug: placebo