healthy males and females with different body sizes
Conditions
Interventions
Group A: abdomen:Subcutaneous injection RAY1225 injection
Group B: upper arm:Subcutaneous injection RAY1225 injection
Group C: Thighs:Subcutaneous injection RAY1225 injection
Sponsors
The first affiliated hospital of guangzhou university of Chinese medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Ability to understand and willingness to sign a written informed consent form; 2.Participant (including partner) agrees to use effective contraception throughout the study period up to 6 months after discontinuation; 3.Male and female participants aged 18~50 years old (including 18 years old and 50 years old); 4.Body mass index (BMI) >=19 kg/m^2 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); 5.Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.
Exclusion criteria
Exclusion criteria: 1. Those who are not suitable for subcutaneous injection (trauma, surgery, allergies or skin lesions, etc.); 2. Known to have any medical or surgical history that may affect safety assessments, including but not limited to: (1). History of chronic pancreatitis, acute pancreatitis, gallbladder stones, and common bile duct stones (those who have no bile duct stones after treatment or have undergone cholecystectomy and no sequelae can be enrolled as appropriate); (2). Any history of gastrointestinal diseases that can affect gastric emptying, such as gastroparesis, postoperative gastric paralysis, idiopathic gastric paralysis, gastroesophageal reflux disease, pyloric stenosis or obstruction, intestinal obstruction, etc., severe chronic gastrointestinal diseases (such as active ulcer, intestinal tuberculosis, etc. within 6 months before randomization), long-term use of drugs that have a direct impact on gastrointestinal motility (including but not limited to domperidone, mosapride, cisapride, etc.); (3). Previous metabolic surgery involving any partial resection and/or reconstruction of the gastrointestinal tract (gastrectomy, gastric bypass, bowel resection, gastroenterostomy, gastrointestinal diversion, gastric stapler or gastric banding, etc.), minimally invasive/endoscopic bariatric devices (intragastric balloons, gastrostomy devices, vagus nerve blockers, duodenal mucosal thermal ablation techniques and left gastric artery embolization, etc.). Participants who have undergone appendectomy, simple hernia repair, or have had a reversible bariatric device (such as gastric banding or intragastric balloon) removed at randomization for more than 12 months may be enrolled; (4). History of frequent nausea, vomiting or irregular gastrointestinal peristalsis caused by any etiology, such as habitual diarrhea, constipation, inflammatory bowel disease or irritable bowel syndrome, etc. (5). Other systemic diseases within 24 weeks prior to randomization, including but not limited to cardiovascular, hepatic, renal, respiratory, endocrine, immunologic, neurological, psychiatric, skin, blood diseases, retinopathy and tumors, etc. (except for those with high BMI combined with hypertension, hyperuricemia, and hyperlipidemia); 3. Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2) (grandparents, parents and siblings); 4. history of hypoglycemic episodes within 12 months prior to randomization; 5. Those with abnormal and clinically significant laboratory tests during the screening period, including but not limited to: (1). Serum amylase or lipase >1.5×ULN; (2). Positive for any of the indicators of hepatitis B surface antigen (HBsAg), hepatitis C antibody, AIDS antibody or treponema pallidum antibody; (3). serum calcitonin>50 ng/L; (4).alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2×ULN (upper limit of normal); Total bilirubin > 1.5×ULN; 6. Patients with abnormal ECG examination during the screening period with clinical significance, or ECG examination QTcF >450ms, or family history of long QT syndrome or Brugada syndrome, etc; 7. Acute illness from the screening stage to the study before the drug use; 8. Vaccinated or planned to be vaccinated during the study period 4 weeks prior to randomization; 9. 2 weeks before randomization or intended to use any prescription drugs, over-the-counter drugs or traditional Chinese medicines in combination during the study period; Part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-lead ECG data;Vital signs;physical examination; | — |
Countries
China
Contacts
Public ContactLing Yan
The first affiliated hospital of guangzhou university of Chinese medicine
Outcome results
None listed