Assessing the safety and effects of HRS-1301 in healthy individuals

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

This study is testing a new drug called HRS-1301 in healthy people to see how safe it is and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06857253 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-1301 in healthy subjects through both single and multiple dose administrations. It consists of two parts and plans to enroll 82 participants, with potential adjustments to sample size and treatment duration based on emerging data. The study aims to gather important information on how the drug behaves in the body and its overall safety profile.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 55 who meet the inclusion criteria.

Not a fit: Patients with gastrointestinal, liver, or kidney diseases, or those with a history of severe trauma or surgeries in the recent past may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of HRS-1301's safety and effectiveness, paving the way for future treatments for hyperlipidemia.

How similar studies have performed: While this study focuses on a specific drug, similar studies assessing the safety and pharmacokinetics of new treatments have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ying Wang

Conditions Hyperlipidemia