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

Phase 1

Recruiting

• Conditions: Hyperlipidemia
• Interventions: Drug: HRS-1301 placebo; Drug: HRS-1301

• Registration Number: NCT06857253
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Status Verified: 2025-03
• Study Start: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. 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.
2. The female subjects must be non-pregnant or non-childbearing potential.
3. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.

Exclusion Criteria

1. 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.
2. Those who had severe trauma or had undergone surgery within 3 months prior to screening, 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 or planned to receive it during the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-1301 placebo group	HRS-1301 placebo	-
HRS-1301 group	HRS-1301	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	From the first dose up to Day 21.

Secondary Outcome Measures

Name	Time	Method
HRS-1301 plasma drug concentration.	Up to 168 hours after the first dosing.
HRS-1301 urine drug concentration.	Up to 168 hours after the first dosing.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China