About this trial
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 55 years (inclusive) at screening, male or female.
Participants must fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the informed consent form (ICF) prior to any study-related procedures.
Agree to use effective contraceptive measures and refrain from sperm or egg donation from the time of signing the ICF until 4 months after the last dose.
Agree to abstain from alcohol, smoking, and food or beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.), and refrain from strenuous exercise from 48 hours prior to dosing until discharge from the study site.
Disqualifiers
History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, psychiatric, neurological, hematological, immunological, or metabolic disorders (e.g., recurrent hypoglycemia of unknown cause) that, in the investigator's opinion, would make the participant unsuitable for participation in this study.
Clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
Presence of diseases that, in the investigator's judgment, may significantly affect drug or nutrient absorption, including clinically significant gastrointestinal disorders (e.g., active inflammatory bowel disease) or symptoms of gastrointestinal disturbance; or any condition that may affect drug absorption, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, or resection of any intestinal segment.
Diagnosis of chronic pancreatitis or history of idiopathic acute pancreatitis, or serum amylase or lipase above the upper limit of normal (ULN) at screening. Participants with a history of acute pancreatitis due to cholelithiasis may be enrolled if they have undergone cholecystectomy.
Trial design
Parallel
Treatments tested in this trial
HS-20136-2
DrugSingle-dose pen of HS-20136-2 injection solution
Placebo
DrugSingle-dose of placebo
HS-20136-2
Drugmulti-dose pen of HS-20136-2 injection solution
placebo
Drugmulti-dose of placebo
Treatment groups
Trial outcomes
Primary outcomes
Number of Adverse Events
A summary of adverse events, including Serious Adverse Events(SAEs)
Secondary outcomes
Area under the plasma concentration-time curve (AUC) of HS-20136-2
AUC of HS-20136-2 after single subcutaneous injection
AUC of HS-20136-2
AUC of HS-20136-2 after multiple subcutaneous injection
Immunogenicity
anti- HS-20136-2 antibody
body weight change
body weight change from baseline
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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