Kidney Impairment
Conditions
Brief summary
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
Interventions
DRUGRAY1225
Administered SC
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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 and \<130 mL/min ； 5. Age, BMI, and sex comparable to those of subjects of 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)；
Exclusion criteria
1. Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds; 2. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; 3. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months or donated blood or bleeding profusely (\> 200 mL) in the 1 months; 4. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test 5. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks Participants with severe renal impairment only: 6. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period; 7. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg) 8. New York heart association (NYHA) class III or IV congestive heart failure 9. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \> 1.5×ULN;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t]) | Baseline through Day 43 |
| PK: Maximum Concentration of RAY1225 | Baseline through Day 43 |
Secondary
| Measure | Time frame |
|---|---|
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) | Baseline through Day 43 |
Countries
China
Outcome results
None listed