A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes (NCT06577428) | Clinical Trial Compass
CompletedPhase 1
A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes
China48 participantsStarted 2024-07-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of RAY1225 From Time Zero to Infinity (AUC[0-∞])
. 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.