A Study of RAY1225 in Participants With Impaired Kidney Function

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 1

Conditions: Kidney Impairment

Treatments: Drug: RAY1225

Study type: Interventional

Funder types: Industry

Identifiers

NCT06613763

RAY1225-24-06

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 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 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;

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

RAY1225 - Mild Renal Impairment

Experimental group

Description:

RAY1225 3mg administered SC to participants with mild renal impairment.

Treatment:

Drug: RAY1225

RAY1225 - Moderate Renal Impairment

Experimental group

Description:

RAY1225 3mg administered SC to participants with moderate renal impairment.

Treatment:

Drug: RAY1225

RAY1225 - Severe Renal Impairment

Experimental group

Description:

RAY1225 3mg administered SC to participants with severe renal impairment.

Treatment:

Drug: RAY1225

RAY1225 - Control

Experimental group

Description:

RAY1225 3 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.

Treatment:

Drug: RAY1225