NCT04862884

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2021-05-03
• Primary completion: 2021-09-03
• Completion: 2021-09-24
• First posted: 2021-04-28
• Last updated: 2021-04-28