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Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants

NCT07752069 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-07

No results posted yet for this study

Summary

This study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. The experimental process includes three stages: screening period, baseline period, and administration observation period.

Conditions

  • Lipoprotein Disorder

Interventions

DRUG

HRS-5346

Dose A, Dose B

DRUG

HRS-5346

Dose B, DoseA

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-09-30
Completion
2026-10-31

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 NCT07752069 on ClinicalTrials.gov