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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06857253

Enrollment

Registered

2025-03-04

Start date

2025-03-18

Completion date

2025-08-11

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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.

Interventions

DRUGHRS-1301

HRS-1301.

DRUGHRS-1301 placebo

HRS-1301 placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs)	From the first dose up to Day 21.

Secondary

Measure	Time frame
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026