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

Pain Clinical Trial

Official title:

A Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, on the Pharmacokinetics of HRS4800 in Healthy Male Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04862884
• Other study ID #: HRS4800-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 3, 2021
• Est. completion date: September 24, 2021

Study information

• Verified date: April 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: li Yue
• Phone: 86-021-61623632
• Email: li.yue[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 24, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• HRS4800 tablets
Drug: HRS4800 tablets Low-dose group, single oral administration Drug: HRS4800 tablets Low-medium dose group, single oral administration Drug: HRS4800 tablets medium -dose group, single oral administration Drug: HRS4800 tablets Medium and high dose group, single oral administration Drug: HRS4800 tablets High-dose group, single oral administration
• placebo
Drug: placebo Low-dose group, single oral administration Drug: placebo Low-medium dose group, single oral administration Drug: placebo medium -dose group, single oral administration Drug: placebo Medium and high dose group, single oral administration Drug: placebo High-dose group, single oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with Adverse Events (AEs)		1-21 days
Primary	Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities		1-21 days
Primary	Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities		1-21 days
Primary	Proportion of Participants with Vital Sign and Physical Examinations Abnormalities		1-21 days
Secondary	Maximum Observed Plasma Concentration (Cmax) of HRS4800,		1-6 days
Secondary	Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,		1-6 days
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,		1-6 days
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800		1-6 days
Secondary	Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,		1-6 days
Secondary	Elimination Rate Constant (?z, or kel) of HRS4800,		1-6 days
Secondary	Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800		1-6 days
Secondary	Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)		1-6 days
Secondary	Total HRS4800 of Fraction of Dose Excreted in Urine (feu)		1-6 days