Type 2 diabetes
Conditions
Interventions
Part A Section SAL0150 Treatment Group:SAL0150 Tablet
Part A Section Placebo Group:Placebo
Part B Section 6a Group: Semedulide inj:Semedulide inj
Part B: 6a Group SAL0150:SAL0150 Tablet
Part B Section 7a Group:SAL0150 Tablet
Part B Section 6b Group:SAL0150 Tablet
Part B Section 7b Group:SAL0150 Tablet
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 People who have fully understood this research and voluntarily signed the written informed consent form. I am capable of complying with the requirements and restrictions listed in the informed consent document. 2 Male or female trial participants aged between 18 and 55 years old (inclusive of 18 and 55 years old); 3 For the screening of the participants in the health trial, the male participants had a body weight of >= 50 kg, and the female participants had a body weight of >= 45 kg; and for Part A, the body mass index (BMI) was within the range of 19.0 to 24.0 kg/m^2, and for Part B, the BMI was within the range of 19.0 to 28.0 kg/m^2 (including the boundary values; BMI = weight / height^2). 4 For the participants in the obesity trial, the screening criteria were: BMI >= 28.0 kg/m^2 and a weight change of less than 5% within 3 months. 5 During the screening process, the results of all examinations (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, and thyroid function, etc.) were normal or, based on the investigator's judgment, the abnormalities were deemed to have no clinical significance. 6 In the 12-lead electrocardiogram examination, for males, the QTcF value should be <= 450 ms, and for females, it should be <= 470 ms. Among them, for group 6b, both males and females need to have a value of <= 450 ms. 7 The participants in the trial or their partners should have no pregnancy plans during the study period and within 3 months after the last administration of the study drug. They voluntarily take effective contraceptive measures (contraceptive pills are prohibited during the study period) to avoid getting pregnant themselves or their partners pregnant, and the participants in the trial do not donate sperm or egg cells (egg cells, oocyte) for reproductive or assisted reproductive purposes.
Exclusion criteria
Exclusion criteria: 1 Pregnant or lactating women, or women of childbearing age whose pregnancy screening results are positive, or women of childbearing age who had unprotected sexual intercourse within 14 days before the first administration of the test; 2 Exclude cases with a history of clinically significant acute drug or food allergy reactions within the past 2 weeks, or with an allergic constitution (such as being allergic to two or more drugs, foods, or pollen), or with a history of allergic disorders (such as asthma, urticaria, eczema, etc.), or where the investigator determines that the subject may or is definitely allergic to the study drug (including similar drugs or control drugs), to any of its excipients, or has a hypersensitivity reaction or a clinically significant significant reaction; 3 Any of the following test results is positive: hepatitis B surface antigen test, hepatitis C virus antibody test, human immunodeficiency virus antibody test, and syphilis spirochete specific antibody test. 4 During the screening process, the serum calcitonin (CT) level was greater than 50 ng/L; 5 Before the first administration, any of the following foods, drugs or treatments were used: (1) Within 12 weeks prior to the first administration, any GLP-1 receptor agonist or similar drugs targeting the same target (such as semaglutide, liraglutide, dulaglutide, exenatide, tiraglutide, or other drugs in the trial stage containing GLP-1 and other related weight loss targets) were used; (2) Within 12 weeks prior to the first administration, systemic glucocorticoids, tricyclic antidepressants with significant impact on weight, psychiatric medications or sedatives were used; (3) Within 12 weeks prior to the first administration, prescription drugs, over-the-counter drugs, herbal medicines and food supplements (including health foods, meal replacement foods, etc.) for weight loss or weight control were used; (4) Within 12 weeks prior to the first administration, acupuncture, physical therapy and other non-drug treatments for weight loss were received; (5) Within 2 weeks prior to the first administration, any prescription drugs, over-the-counter drugs, herbal medicines and food supplements (including vitamins, health foods, etc.) were used; (6) Within 48 hours prior to the first administration, foods or beverages containing grapefruit (mandarin orange) or foods or beverages containing caffeine (such as strong tea, coffee, cola) or foods or beverages rich in xanthine (such as chocolate, cocoa beans) were consumed, or it was agreed not to consume foods or beverages containing caffeine (such as strong tea, coffee, cola) or foods or beverages rich in xanthine (such as chocolate, cocoa beans) within 48 hours prior to the first administration and until the end of the study period. 6 Have any of the following diseases or medical histories: (1) Obesity caused by secondary diseases or medications, including: elevated cortisol levels (such as Cushing's syndrome), obesity resulting from damage to the pituitary and hypothalamus, obesity caused by reducing or discontinuing weight-loss medications, etc.; (2) Type 1 or Type 2 diabetes; (3) Previous or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/requiring treatment gallbladder diseases (except for trial participants who have undergone gallbladder removal and have been judged by the researchers to be eligible for inclusion); (4) Thyroid C-cell canc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity-related indicators;pharmacokinetic parameters;Safety index; | — |
Countries
China
Contacts
Public ContactZhihong Xie
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed