Phase
Condition
Glomerulonephritis
Treatment
Placebo
HRS-5965
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy subjects study
Healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signingthe informed consent);
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
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 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
The researcher has determined that there may be diseases or medical conditions thataffect the absorption, distribution, metabolism and excretion of drugs or reducecompliance;
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 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
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);
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
Connect with a study center
The Affiliated hospital of QingDao University
Qingdao, Shandong 266000
ChinaSite Not Available
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