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

NCT04802811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-12-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2021-11-10
Completion
2021-11-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802811 on ClinicalTrials.gov