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

NCT06857253 | Completed Phase 1

• 1 other identifier: HRS-1301-101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  From the first dose up to Day 21.

Secondary Outcomes (2)

• 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.

Study Arms (2)

HRS-1301 group

EXPERIMENTAL

Drug: HRS-1301

HRS-1301 placebo group

PLACEBO COMPARATOR

Drug: HRS-1301 placebo

Interventions

HRS-1301 DRUG

HRS-1301.

HRS-1301 group

HRS-1301 placebo DRUG

HRS-1301 placebo.

HRS-1301 placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 18, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)