Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency

Last updated: October 22, 2024
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Overall Status: Completed

Phase

1

Condition

Glomerulonephritis

Treatment

Placebo

HRS-5965

Clinical Study ID

NCT05505955
HRS-5965-101
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts:

Part 1: single ascending dose, randomized, double-blind study,with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study,with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy subjects study
  1. Healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signingthe informed consent);

  2. 18.5kg/m2 ≤BMI<30 kg/m2, and the weight of men should be ≥ 50kg, and that of womenshould be ≥ 45kg.

Study on subjects with renal insufficiency

  1. Age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent),both men and women can;

  2. 18.5kg/m2≤BMI<30 kg/m2;

  3. The estimated glomerular filtration rate of subjects with chronic renalinsufficiency conforms to 15 ≤ EGFR < 30 ml/min/1.73m2 (calculated according toCKD-EPI formula, see Appendix 2 of the scheme).

Exclusion

Exclusion Criteria:

  • Healthy subjects study
  1. The researcher has determined that there may be diseases or medical conditions thataffect the absorption, distribution, metabolism and excretion of drugs or reducecompliance;

  2. The estimated glomerular filtration rate conforms to EGFR < 90 ml/min/1.73m2 (calculated according to CKD-EPI formula, see Appendix 2 of the scheme);

  3. According to the judgment of the researcher, any physiological or psychologicaldisease or condition that may increase the risk of the test, affect the subject'scompliance with the protocol, or affect the subject's completion of the test.

Study on subjects with renal insufficiency

  1. Those who received renal replacement therapy within 12 weeks before screening; Orthe two tests in the screening period indicate that the renal function is unstable (the results in the screening period meet the diagnostic criteria of 2012 KDIGOacute renal injury, or the changes that do not meet the above criteria but arejudged to be clinically significant by the researcher. If there are reasonablereasons, the third test is allowed, and the interval between two consecutive testsshould be more than 3 days but not more than 7 days);

  2. According to the judgment of the researcher, the subject has any of the following:in the state of progression or prognosis of disease (including primary renaldisease, complications and other complications); The treatment plan needs to beadjusted at any time; Any physical or mental disease or condition that may increasethe risk of the test, affect the subject's compliance with the protocol, or affectthe subject's completion of the test.

Study Design

Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 08, 2022
Estimated Completion Date:
November 03, 2023

Connect with a study center

  • The Affiliated hospital of QingDao University

    Qingdao, Shandong 266000
    China

    Site Not Available

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