This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.
Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
Males or females aged 18-55 years (inclusive);
Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG);
At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.
During screening, electrocardiogram (ECG) indicated that QTcF>450 ms in males and QTcF> 470 ms in females, as well as other abnormal ECG and vital signs that were judged by the researchers to have clinical significance;
There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes, hypothyroidism or hyperthyroidism, etc.);
There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or symptomatic gallbladder disease;
Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases);
Parallel
SHR-2906 Injection
DrugSHR-2906 injection, in different doses.
SHR-2906 Injection Placebo
DrugSHR-2906 injection placebo.
Incidence of adverse events (AEs).
Incidence of serious adverse events (SAEs).
Maximum concentration (Cmax).
Time of maximum concentration (Tmax).
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
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