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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemia

Treatments: Drug: HRS-1301 placebo; Drug: HRS-1301

Study type: Interventional

Funder types: Industry

Identifiers

NCT06857253

HRS-1301-101

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

HRS-1301 group

Experimental group

Treatment:

Drug: HRS-1301

HRS-1301 placebo group

Placebo Comparator group

Treatment:

Drug: HRS-1301 placebo