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Completed

NCT Number: NCT06613763

A Study of RAY1225 in Participants With Impaired Kidney 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

RAY1225

Drug

Administered SC

Primary outcomes

  1. 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

  2. PK: Maximum Concentration of RAY1225

    Time frame: Baseline through Day 43

Secondary outcomes

  1. Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)

    Time frame: Baseline through Day 43

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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