Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 1

Conditions: Kidney Impairment

Treatments: Drug: ZSP1273

Study type: Interventional

Funder types: Industry

Identifiers

NCT06248567

ZSP1273-23-14

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Experimental 1: participants with severe renal impairment

Experimental group

Description:

8 participants with severe renal impairment will be given 600mg of ZSP1273

Treatment:

Drug: ZSP1273

Experimental 2: healthy participants

Experimental group

Description:

8 participants with normal renal function will be given 600mg of ZSP1273

Treatment:

Drug: ZSP1273