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Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C

NCT05531097 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-01-03

No results posted yet for this study

Summary

This is a Phase I, single-dose and multiple dose escalation clinical trial for HSK31679 conducted in chinese healthy volunteers and LDL-C elevated subjects. The safety, tolerability, food-impact,pharmacokinetics and pharmacodynamics of HSK31679 tablet in healthy volunteers and LDL-C elevated volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design

Conditions

  • Healthy
  • Elevated LDL-C

Interventions

DRUG

HSK31679

Single or multiple oral doses of HSK31679

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2022-09-21
Completion
2022-12-08

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 NCT05531097 on ClinicalTrials.gov