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A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration

NCT05274516 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-04-05

No results posted yet for this study

Summary

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.

Conditions

  • Chronic Cough

Interventions

DRUG

HRS-2261 tablet、placebo

HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.

DRUG

HRS-2261 tablet、placebo

HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.

Sponsors & Collaborators

  • Guangdong Hengrui Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2022-10-25
Completion
2022-10-25

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 NCT05274516 on ClinicalTrials.gov