Search / Trial NCT06613763

A Study of RAY1225 in Participants With Impaired Kidney Function

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Sep 23, 2024

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Description

No description provided

Gender

ALL

Eligibility criteria

  • 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;

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Xiamen, Fujian, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0