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NCT06775834CompletedPhase 1

Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function

Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects

Source: ClinicalTrials.gov · Last updated 10 Sept 2025

Brief summary (registry, in English)

The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
24 (actual)
First submitted
9 Jan 2025
Start date
11 Feb 2025
Primary completion date
23 Jul 2025
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
NCT number
NCT06775834

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 24
  • From 11 Feb 2025 to the primary completion date, 23 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
  • Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
  • Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.

Other illness

  • Suspected allergy to the study drug or any component of the study drug;
  • Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;
  • People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
  • Patients with a history of gastric or intestinal surgery that may affect drug absorption;
  • Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;

Who the study is looking for

  • Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
  • Male or female subjects aged 18 to 65 (including 18 and 65);
  • Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sichuan Provincial People's Hospital
Coordinator of this site? Confirm its status
ChengduChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.