A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic of SYH9017 in Chinese Participants With Overweight and Obesity Following Single and Multiple Doses
This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.
• Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of either gender;
• SAD phase: Body Mass Index (BMI) = weight (kg)/height\^2 , with BMI in the range of 24.0-28.0 kg/m\^2 (inclusive); MAD phase: Weight ≥70 kg (for males) or ≥60 kg (for females), and BMI = weight (kg)/height\^2 , with BMI ≥28.0 kg/m\^2;
• Weight change \<5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at screening) / weight at screening \* 100%;
• Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, glycated hemoglobin, coagulation function, infectious disease screening, thyroid function, calcitonin, etc.) show normal results or abnormal results deemed not clinically significant by the investigator;
• Able to read and understand the written informed consent related to the study information, fully aware of the study content, process, and possible adverse reactions, voluntarily sign the informed consent form before the trial, and ensure that they will personally participate in any procedures; Participants and their partners agree to use effective non-hormonal contraception methods (such as condoms, inert intrauterine devices, female barrier methods \[cervical cap or diaphragm with spermicide\], vaginal contraceptive rings, etc.) from the time of signing the informed consent form until 6 months after the last dose, or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.); Male participants do not plan to donate sperm from the time of signing the informed consent form until 6 months after the last dose, and female participants do not plan to donate eggs from the time of signing the informed consent form until 6 months after the last dose.