Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

Phase 1

Completed

• Conditions: Kidney Impairment
• Interventions: Drug: ZSP1273

• Registration Number: NCT06248567
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-15
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-30
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 1: participants with severe renal impairment	ZSP1273	8 participants with severe renal impairment will be given 600mg of ZSP1273
Experimental 2: healthy participants	ZSP1273	8 participants with normal renal function will be given 600mg of ZSP1273

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	0~120hours	The Cmax of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)	0~120hours	The AUClast of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.

Secondary Outcome Measures

Name	Time	Method
Number of participants with drug-related adverse events as assessed by CTCAE v5.0	DAY1~DAY12

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, China