A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects

Last updated: March 31, 2025
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Dyslipidemia

Hypercholesterolemia

Hypertriglyceridemia

Treatment

HRS-1301

HRS-1301 placebo

Clinical Study ID

NCT06857253
HRS-1301-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy male and female subjects must be at least 18 years old and no more than 55years old on the date of signing the ICF.

  2. The female subjects must be non-pregnant or non-childbearing potential.

  3. Subjects must understand the study procedures and methods, voluntarily participatein this study and sign the ICF in person.

Exclusion

Exclusion Criteria:

  1. Have a gastrointestinal, liver or kidney disease or other condition known to affectdrug absorption, distribution, metabolism and excretion or to reduce adherence, asdetermined by the investigator.

  2. Those who had severe trauma or had undergone surgery within 3 months prior toscreening, or planned to undergo surgery during the trial.

  3. Have a history of repeated drug allergies.

  4. People who have used any drug in the 2 weeks prior to screening.

  5. Those who received live (attenuated) vaccine within 4 weeks prior to screening orplanned to receive it during the trial.

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: HRS-1301
Phase: 1
Study Start date:
March 18, 2025
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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