A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Severe Kidney Impairment on the Pharmacokinetics, Safety and Tolerability of ZSP1273

ZSP1273-23-14

This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.

2024-01-15

2024-04-30

2024-05-30

Recruiting

Early phase I

16

Inclusion Criteria: 1. Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared); 2. Ability to understand and willingness to sign a written informed consent form; Participants with normal renal function only: 3. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant. 4. Glomerular filtration rate (GFR)≥ 90 mL/min 5. Age, BMI, and sex comparable to those of subjects of severe renal impairment Participants with severe renal impairment only: 6. Diagnosis of CKD (any indicators of renal impairment or GFR \< 60 mL/min/1.73 m2 for more than 3 months) 7. glomerular filtration rate (GFR) between 15-29 mL/min (including boundary) Exclusion Criteria: 1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. 2. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months. 3. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test 4. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks Participants with severe renal impairment only: 5. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period; 6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg) 7. New York heart association (NYHA) class III or IV congestive heart failure 8. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \> 1.5×ULN;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2024-02-08