Search / Trial NCT06613763

A Study of RAY1225 in Participants With Impaired Kidney Function

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

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called RAY1225 to see how it behaves in the body of people with kidney impairment compared to those with healthy kidneys. The researchers want to understand how quickly RAY1225 enters the bloodstream and how long it stays in the body for participants who have kidney issues. The study is currently looking for volunteers aged between 18 and 80 who meet specific health criteria, such as having a certain body weight and not having severe allergies or serious health conditions.

If you decide to participate, you will undergo some health assessments to ensure you're eligible, including tests for kidney function and overall health. Participants can expect to provide informed consent and may have to attend several visits to the clinic where they will be monitored throughout the study. This research is important because it could help improve treatments for those with kidney problems, and your involvement could contribute to valuable medical knowledge.

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 Guangdong Raynovent Biotech Co., Ltd

Guangdong Raynovent Biotech Co., Ltd. is a pioneering biotechnology company based in Guangdong, China, dedicated to advancing innovative therapeutic solutions in the field of respiratory and immunological disorders. With a strong focus on research and development, Raynovent leverages cutting-edge technology and a robust pipeline of products to enhance patient outcomes. The company's commitment to clinical excellence is reflected in its rigorous clinical trial programs, which aim to validate the safety and efficacy of its novel therapies. By fostering collaboration with leading academic institutions and regulatory bodies, Guangdong Raynovent Biotech is positioned to make significant contributions to global health through its transformative approaches to disease management.

Locations

Xiamen, Fujian, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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