HRS-1301 tablets in adults with healthy and impaired kidney function

A Single-dose, Open-label Phase I Clinical Trial Comparing the Pharmacokinetics, Safety and Pharmacodynamics of HRS-1301 Tablets in Subjects With Mild, Moderate and Severe Renal Insufficiency and Healthy Subjects

This trial will test how HRS-1301 tablets are processed by the body in adults with normal or reduced kidney function to help set safe dosing for people with renal impairment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07322016 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional pharmacokinetic study comparing HRS-1301 tablet exposure in healthy adults and adults with mild, moderate, or severe renal impairment. Adult volunteers aged 18–65 who meet BMI and weight criteria will receive HRS-1301 with serial blood sampling to measure drug concentrations and standard safety monitoring. The main goal is to characterize how reduced glomerular filtration affects drug clearance and to inform dosing recommendations for patients with impaired kidneys. The trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and conducted at Sichuan Provincial People's Hospital in Chengdu.

Who should consider this trial

Good fit: Adults 18–65, either healthy or with mild to severe renal impairment (GFR 15–89 mL/min) who meet the trial's BMI, weight, and other inclusion criteria are appropriate candidates.

Not a fit: People with end-stage kidney disease (GFR <15 mL/min or on dialysis), known allergy to the drug, serious cardiac conditions, or those outside the age/BMI limits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could identify safer, adjusted HRS-1301 dosing for patients with reduced kidney function to lower side effects while maintaining effect.

How similar studies have performed: Pharmacokinetic studies in people with renal impairment are a standard, well-established approach and have successfully guided dosing for many lipid-lowering and other drugs.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 65 (including 18 and 65);
3. Body mass index (BMI) ranges from 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
4. The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min; Subjects with severe renal function impairment: 15\~29 mL/min.

Exclusion Criteria:

1. Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those allergic to any drug or food), or those known to be allergic to any component of the studied drug;
2. Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the pointed point, a history of clinically significant T-wave changes, myocardial infarction, or angina pectoris;
3. Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have been treated without recurrence signs and resected cervical intraepithelial neoplasia);
4. Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
5. Those who have suffered severe trauma or undergone major surgical operations within the three months prior to screening, or who plan to undergo surgery during the trial period;
6. Those who have participated in any clinical trials of drugs or medical devices within three months prior to screening, or those who are still within five half-lives of the drug before screening (whichever is longer);
7. Those who have donated blood of ≥ 400 mL within 4 weeks before screening, or have suffered severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks;
8. Those who received live (attenuated) vaccines within 4 weeks prior to screening or those who plan to receive them during the trial;
9. Those with potential difficulties in blood collection and a history of fainting at the sight of needles or blood;
10. For patients with renal insufficiency,those who have received renal replacement therapy (such as peritoneal dialysis, hemodialysis, etc.) within 3 months prior to the screening or during the expected trial period;
11. For patients with renal insufficiency，screening individuals with underlying diseases that induce chronic kidney disease within the previous three months and are judged by researchers to be poorly controlled, such as diabetic patients with HbA1c \> 10%, and hypertensive patients with systolic blood pressure \> 180 mmHg and diastolic blood pressure \> 120 mmHg, etc.

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Ying Wang, PhD

Conditions Hyperlipidemias