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Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343

NCT07101965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-08-03

No results posted yet for this study

Summary

To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration

Conditions

  • Health Volunteer

Interventions

DRUG

RSS0343 tablets ；placebo

RSS0343 tablets and placebo were given orally as a single dose

DRUG

RSS0343 tablets ；placebo

RSS0343 tablets and placebo were taken orally multiple times

Sponsors & Collaborators

  • Jiangsu HengRui Medicine 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
2024-04-07
Primary Completion
2024-11-06
Completion
2024-11-06

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 NCT07101965 on ClinicalTrials.gov