Status:
COMPLETED
A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06577428
Start Date
July 30 2024
End Date
October 8 2024
Last Update
March 19 2025
Active Locations (1)
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1
Guangdong Hospital of Chinese Medicine
Guanzhou, Guangdong, China