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Completed

NCT Number: NCT06577428

A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes

The purpose of this study is to compare the amount of RAY1225 that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of RAY1225 will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 7 weeks, including screening.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Hospital of Chinese Medicine

Guanzhou, Guangdong, 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) ≥19 kg/m2 and total body weight >50 kg for male, >45 kg for 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;
  • Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion criteria

  • Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
  • Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening,or who cannot stop using any tobacco products during the study period;
  • Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
  • Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
  • Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
  • Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • History of dysphagia or any gastrointestinal disorder that affect absorption;
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

Treatment and study plan

RAY1225

Drug

administered SC

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of RAY1225 From Time Zero to Infinity (AUC[0-∞])

    Time frame: DAY1~43

  2. PK: Maximum Concentration (Cmax) of RAY1225

    Time frame: DAY1~43

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: DAY1~43

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

Effect of Injection Site on the Relative Bioavailability of a Single Dose of RAY1225 in Subjects With Low and High Body Mass Index

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Mar 19, 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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