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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
Sponsored by
Chengdu Suncadia Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

  1. Healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent);
  2. 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

  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 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

  1. 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;
  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 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

  1. 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);
  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 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

Experimental

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

First Posted
August 16, 2022
Last Updated
October 13, 2022
Sponsor
Chengdu Suncadia Medicine Co., Ltd.
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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.
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
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.
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
Pre-dose to 144 hours post-dose
Title
Peak plasma concentration (Cmax) on Day 1 for Part 1 and Part 3
Time Frame
Pre-dose to 144 hours post-dose
Title
Time to maximum plasma concentration (Tmax) on Day 1 for Part 1 and Part 3
Time Frame
Pre-dose to 144 hours post-dose
Title
• 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
Title
Peak plasma concentration (Cmax) on Day 1 and Day 10 for Part 2
Time Frame
Pre-dose to 144 hours post-dose
Title
Time to maximum plasma concentration (Tmax) on Day 1 and Day 10 for Part 2
Time Frame
Pre-dose to 144 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siai Sun
Phone
18036618062
Email
siai.sun@hengrui.com
Facility Information:
Facility Name
The Affiliated hospital of QingDao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Cao, Doctor
Phone
0532-82911767
Email
Caoyu1767@126.com
First Name & Middle Initial & Last Name & Degree
Guangqun Xing, Doctor
Phone
0532-82911767
Email
gqx99monash@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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