NCT06613763CompletedPhase 1
Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function
Guangdong Raynovent Biotech Co., Ltd1 site in 1 country32 target enrollmentStarted: September 11, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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);
- •Ability to understand and willingness to sign a written informed consent form;
- •Participants with normal renal function only:
- •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；
- •Glomerular filtration rate (GFR)≥ 90 mL/min and <130 mL/min ；
- •Age, BMI, and sex comparable to those of subjects of renal impairment；
- •Participants with severe renal impairment only:
- •Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months)；
Exclusion Criteria
- •Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds;
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- •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;
- •Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- •Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- •Participants with severe renal impairment only:
- •Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
- •Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
- •New York heart association (NYHA) class III or IV congestive heart failure
- •Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;
Arms & Interventions
RAY1225 - Mild Renal Impairment
Experimental
RAY1225 3mg administered SC to participants with mild renal impairment.
Intervention: RAY1225 (Drug)
RAY1225 - Moderate Renal Impairment
Experimental
RAY1225 3mg administered SC to participants with moderate renal impairment.
Intervention: RAY1225 (Drug)
RAY1225 - Severe Renal Impairment
Experimental
RAY1225 3mg administered SC to participants with severe renal impairment.
Intervention: RAY1225 (Drug)
RAY1225 - Control
Experimental
RAY1225 3 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.
Intervention: RAY1225 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
Time Frame: Baseline through Day 43
PK: Maximum Concentration of RAY1225
Time Frame: Baseline through Day 43
Secondary Outcomes
- Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)(Baseline through Day 43)
Investigators
Study Sites (1)
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