This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial consisting of two parts. Part 1 includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts conducted in healthy participants. Part 2 is a multiple ascending dose (MAD) trial enrolling HBeAg-negative chronic hepatitis B (CHB) participants with suppressed HBV DNA under stable nucleos(t)ide analog (NA) therapy.
Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent;
Aged between 18 and 55 years old (inclusive) at the time of informed consent, male or female;
Body mass index meets specified criteria;
Physical examination, vital signs, laboratory tests, electrocardiogram and imaging examinations at screening are normal or abnormalities are considered clinically insignificant;
Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator).
History of clinically significant diseases involving cardiovascular, hematologic and lymphatic, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy).
Vital signs or laboratory examinations at screening meet the exclusion cut-off values specified in the protocol.
Use of any prescription drugs, over-the-counter medications, vitamin products or herbal medicines within 2 weeks prior to the first dose (topical medications with local effects are excluded).
Sequential
ACT201 Injection
DrugPart 1 SAD (Single Ascending Dose): Single-dose subcutaneous injection per assigned dose group. Part 1 MAD (Multiple Ascending Dose) and Part 2: Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.
ACT201 Injection Placebo
DrugPart 1 SAD (Single Ascending Dose): Single-dose subcutaneous injection administered per assigned dose group. Part 1 MAD (Multiple Ascending Dose) and Part 2: Subcutaneous injection administered per assigned dose group; the treatment duration shall comply with the study protocol.
Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Assessments include vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs).
Plasma drug concentrations in healthy participants and participants withCHB
Area Under the Concentration-Time Curve from time zero to the last measurable concentration（AUC₀-ₜ）
Area Under the Concentration-Time Curve from time zero to infinity（AUC₀-∞）
Apparent Volume of Distribution（Vd/F）
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Xiamen Amoytop Biotech Co., Ltd.
Lead sponsor
Huashan Hospital
Collaborator
