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

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RAY1225 to see how well it is absorbed into the bloodstream and how quickly the body eliminates it. The researchers will compare injections given under the skin in different areas: the upper arm, thigh, and abdomen. They are looking for healthy men and women of various body sizes to participate, and the study will last about 7 weeks. Throughout the trial, participants will be monitored for any side effects and how well they tolerate the medication.

To be eligible for this study, participants must be between 18 and 62 years old, have a body mass index (BMI) of at least 19, and weigh over 50 kg for men and over 45 kg for women. They should be in good health, meaning they have normal physical exams and lab results. However, individuals with certain allergies, those who have recently taken medications, or those with specific health issues will not be able to participate. If you join the study, you will be helping researchers learn more about RAY1225, and you can expect regular check-ins and assessments throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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);
• • 2. Ability to understand and willingness to sign a written informed consent form;
• • 3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.
• Exclusion Criteria:
• • 1. 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;
• • 2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
• • 3. 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;
• • 4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
• • 5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
• • 6. 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);
• • 7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
• • 8. Females who are pregnant, lactating, or likely to become pregnant during the study.
• • 9. History of dysphagia or any gastrointestinal disorder that affect absorption;
• • 10. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2