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CompletedNCT07322016Updated Sep 30, 2026

A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function

A Phase 1 interventional study of HRS-1301 Tablet in Hyperlipidemias, sponsored by Shandong Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

Updated Sep 30, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

02

Conditions studied

  • Hyperlipidemias

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03

In context

Hyperlipidemias

861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.

This study's enrollment of 36 is below the median of 88 across 735 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Sign the 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. (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 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

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 ( grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the pointed point, a history of 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 > 10%, and hypertensive patients with systolic blood pressure > 180 mmHg and diastolic blood pressure > 120 mmHg, etc.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    HRS-1301 Tablet Group

    Treatment for oral medication.

    Drug: HRS-1301 Tablet

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum concentration (Cmax).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  2. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  3. Area under the concentration-time curve from time zero to infinity (AUC0-inf).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

Secondary outcomes

  1. Time of maximum concentration (Tmax).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  2. Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  3. Elimination half-life (t1/2).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  4. Apparent clearance (CL/F).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  5. Apparent volume of distribution (Vz/F).

    Pharmacokinetic parameters of HRS-1301 in plasma.

    Time frame: 0 hour to 8 days after dosing.

  6. Cumulative drug excretion in urine (Ae,urine).

    Pharmacokinetic parameters of HRS-1301 in urine.

    Time frame: 0 hour to 6 days after dosing.

  7. Cumulative drug excretion fraction in urine (fe,urine).

    Pharmacokinetic parameters of HRS-1301 in urine.

    Time frame: 0 hour to 6 days after dosing.

  8. Incidence of adverse events (AEs).

    Safety and tolerability.

    Time frame: 0 hour to 8 days after dosing.

  9. Incidence of serious adverse events (SAEs).

    Safety and tolerability.

    Time frame: 0 hour to 8 days after dosing.

07

Study locations

1 site
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 30, 2026
Primary completion
Oct 2026→Aug 4, 2026 (actual)
Sep 30, 2026
Study completion
Oct 2026→Aug 4, 2026 (actual)
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Recruiting→Completed
    Primary completion Oct 2026→Aug 4, 2026 (now actual)
    Study completion Oct 2026→Aug 4, 2026 (now actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07322016
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Jan 13, 2026
Primary completion
Aug 4, 2026
Completion
Aug 4, 2026
Last update
Sep 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: HRS-1301

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