Clinical trial NCT06613763: A Study of RAY1225 in Participants With Impaired Kidney Function
Official title: Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Impairment
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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;

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
timeFrame: Baseline through Day 43
measure: PK: Maximum Concentration of RAY1225
timeFrame: Baseline through Day 43
Secondary outcomes:
measure: Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
timeFrame: Baseline through Day 43
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: