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Completed

NCT Number: NCT06857253

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects must be at least 18 years old and no more than 55 years old on the date of signing the ICF.
  • The female subjects must be non-pregnant or non-childbearing potential.
  • Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.

Exclusion criteria

  • Have a gastrointestinal, liver or kidney disease or other condition known to affect drug absorption, distribution, metabolism and excretion or to reduce adherence, as determined by the investigator.
  • Those who had severe trauma or had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the trial.
  • Have a history of repeated drug allergies.
  • People who have used any drug in the 2 weeks prior to screening.
  • Those who received live (attenuated) vaccine within 4 weeks prior to screening or planned to receive it during the trial.

Treatment and study plan

HRS-1301

Drug

HRS-1301.

HRS-1301 placebo

Drug

HRS-1301 placebo.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From the first dose up to Day 21.

Secondary outcomes

  1. HRS-1301 plasma drug concentration.

    Time frame: Up to 168 hours after the first dosing.

  2. HRS-1301 urine drug concentration.

    Time frame: Up to 168 hours after the first dosing.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-blind and Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 Following Single and Multiple Dose Administration in Healthy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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