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

Primary Purpose

Glomerulonephritis

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HRS-5965

Placebo

About this trial

This is an interventional treatment trial for Glomerulonephritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The Affiliated hospital of QingDao UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1

Part 2

Part 3

Arm Description

single ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions. The food impact study consisted of 10 subjects, 8 of whom received HRS-5965 tablets and 2 of whom received placebo. The remaining cohorts required 8 subjects each, with 6 receiving HRS-5965 tablets and 2 receiving placebo.

Multiple ascending dose, randomized, double-blind study，with 4 dose groups preset; Each dose group consisted of 8 healthy adult subjects randomly assigned 6:2 to HRS-5965 tablets or placebo.

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. Subjects took HRS5965 tablets.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT05505955

First Posted

August 16, 2022

Last Updated

October 13, 2022

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05505955

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 8, 2022 (Actual)

Primary Completion Date

April 10, 2023 (Anticipated)

Study Completion Date

April 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu Suncadia Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glomerulonephritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Single-dose and multi-dose, dose escalation, placebo-controlled study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1

Arm Type

Experimental

Arm Description

Arm Title

Part 2

Arm Type

Experimental

Arm Description

Multiple ascending dose, randomized, double-blind study，with 4 dose groups preset; Each dose group consisted of 8 healthy adult subjects randomly assigned 6:2 to HRS-5965 tablets or placebo.

Arm Title

Part 3

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

HRS-5965

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects took Placebo in Part 1 and Part 2.

Primary Outcome Measure Information:

Title

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

Time Frame

up to 24 days

Secondary Outcome Measure Information:

Title

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

Time Frame