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Completed

NCT Number: NCT05505955

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Affiliated hospital of QingDao University

Qingdao, Shandong, 266000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects study
  • Healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent);
  • 18.5kg/m2 ≤BMI<30 kg/m2, and the weight of men should be ≥ 50kg, and that of women should be ≥ 45kg.

Study on subjects with renal insufficiency

  • Age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent), both men and women can;
  • 18.5kg/m2≤BMI<30 kg/m2;
  • The estimated glomerular filtration rate of subjects with chronic renal insufficiency conforms to 15 ≤ EGFR < 30 ml/min/1.73m2 (calculated according to CKD-EPI formula, see Appendix 2 of the scheme).

Exclusion criteria

  • Healthy subjects study
  • The researcher has determined that there may be diseases or medical conditions that affect the absorption, distribution, metabolism and excretion of drugs or reduce compliance;
  • 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);
  • According to the judgment of the researcher, any physiological or psychological disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.

Study on subjects with renal insufficiency

  • Those who received renal replacement therapy within 12 weeks before screening; Or the 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 KDIGO acute renal injury, or the changes that do not meet the above criteria but are judged to be clinically significant by the researcher. If there are reasonable reasons, the third test is allowed, and the interval between two consecutive tests should be more than 3 days but not more than 7 days);
  • 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 renal disease, complications and other complications); The treatment plan needs to be adjusted at any time; Any physical or mental disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.

Treatment and study plan

HRS-5965

Drug

Subjects took HRS5965 tablets in Part 1, Part 2 and Part 3.

Placebo

Drug

Subjects took Placebo in Part 1 and Part 2.

Primary outcomes

  1. The incidence and severity of adverse events to assess safety and tolerability

    Time frame: up to 24 days

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) on Day 1 for Part 1 and Part 3

    Time frame: Pre-dose to 144 hours post-dose

  2. Peak plasma concentration (Cmax) on Day 1 for Part 1 and Part 3

    Time frame: Pre-dose to 144 hours post-dose

  3. Time to maximum plasma concentration (Tmax) on Day 1 for Part 1 and Part 3

    Time frame: Pre-dose to 144 hours post-dose

  4. • Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 10 for Part 2

    Time frame: Pre-dose to 144 hours post-dose

  5. Peak plasma concentration (Cmax) on Day 1 and Day 10 for Part 2

    Time frame: Pre-dose to 144 hours post-dose

  6. Time to maximum plasma concentration (Tmax) on Day 1 and Day 10 for Part 2

    Time frame: Pre-dose to 144 hours post-dose

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of Single and Multiple Dose of HRS-5965 Tablets in Healthy Subjects, and the Food Effect on Pharmacokinetics, and Pharmacokinetics in Subjects With Impaired Renal Function

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2022
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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