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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: HRS4800 tablets; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: li Yue; Phone Number: 86-021-61623632; Email: li.yue@hengrui.com
• Study Contact Backup: Name: Miaoyan Chen; Phone Number: 86- 021-61623632; Email: Miaoyan.chen@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: 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
Experimental: HRS4800 tablets	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants with Adverse Events (AEs)	1-21 days
Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities	1-21 days
Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities	1-21 days
Proportion of Participants with Vital Sign and Physical Examinations Abnormalities	1-21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of HRS4800,	1-6 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,	1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,	1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800	1-6 days
Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,	1-6 days
Elimination Rate Constant (λz, or kel) of HRS4800,	1-6 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800	1-6 days
Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)	1-6 days
Total HRS4800 of Fraction of Dose Excreted in Urine (feu)	1-6 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 3, 2021
• Primary Completion (Anticipated): September 3, 2021
• Study Completion (Anticipated): September 24, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HRS4800-101

Drug and device information, study documents

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