A Study of RAY1225 in Participants With Impaired Kidney Function

Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function

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.

Study Overview

• Status: Completed
• Conditions: Kidney Impairment
• Intervention / Treatment: Drug: RAY1225

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAY1225 - Mild Renal Impairment; RAY1225 3mg administered SC to participants with mild renal impairment.	Drug: RAY1225; Administered SC
Experimental: RAY1225 - Moderate Renal Impairment; RAY1225 3mg administered SC to participants with moderate renal impairment.	Drug: RAY1225; Administered SC
Experimental: RAY1225 - Severe Renal Impairment; RAY1225 3mg administered SC to participants with severe renal impairment.	Drug: RAY1225; Administered SC
Experimental: RAY1225 - Control; RAY1225 3 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.	Drug: RAY1225; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)	Baseline through Day 43

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: RAY1225-24-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No