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

NCT04862884 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2021-09-03
Completion
2021-09-24

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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 NCT04862884 on ClinicalTrials.gov