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Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects

NCT06441227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-04-29

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.

Conditions

  • Lipoprotein Disorder Disease

Interventions

DRUG

HRS-5346 tablets

Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.

DRUG

placebo

Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.

Sponsors & Collaborators

  • Shandong Suncadia 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
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2025-01-09
Completion
2025-01-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06441227 on ClinicalTrials.gov