To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B
Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg.
Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant.
Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug.
Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods).
Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing.
Parallel
HECN30227 injection(SAD)
Drugsingle subcutaneous administrations
Placebo(MAD)
Drug0.9% Sodium Chloride Injection
Placebo(SAD)
Drug0.9% Sodium Chloride Injection
HECN30227 injection (MAD)
Drugmultiple subcutaneous administrations
Number of Adverse Events In Part 1
A summary of adverse events, including Serious Adverse Events(SAEs)
Number of Adverse Events In Part 2
A summary of adverse events, including Serious Adverse Events(SAEs)
Peak Plasma Concentration (Cmax) of single dose
Peak Plasma Concentration (Cmax) of Multiple dose
Area under the plasma concentration-time curve(AUC0-t）
Time to the peak plasma concentration (Tmax)
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