NCT04802811

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics of Oral SHR2150 in Healthy Subjects With Single Dose of SHR2150 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150. will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	SHR2150；Placebo	Single dose；SHR2150-dose 1 or Placebo-dose 1
DRUG	SHR2150；Placebo	Single dose；SHR2150-dose 2 or Placebo-dose 2
DRUG	SHR2150；Placebo	Single dose；SHR2150-dose 3 or Placebo-dose 3
DRUG	SHR2150；Placebo	Single dose；SHR2150-dose 4 or Placebo-dose 4
DRUG	SHR2150；Placebo	Single dose；SHR2150-dose 5 or Placebo-dose 5

Timeline

• Start date: 2021-03-22
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2021-03-17
• Last updated: 2021-12-28

Locations

1 site across 1 country: China