Early safety study of ACT201 injection in healthy adults and chronic hepatitis B

Trial details

Who runs it

Xiamen Amoytop Biotech Co., Ltd.

Trial code

NCT07741461

Record updated

17 August 2026

Original description

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.Read full original descriptionShow less

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, Drug Concentration-QTc Relationship, and Immunogenicity Profiles of Single and Multiple Doses of ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B

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.

Inclusion: Part 1:; 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; Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation; Part 2:; 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 65 years old (inclusive) at the time of informed consent, male or female; Body mass index meets specified criteria; HBsAg-positive or HBV DNA-positive for at least 6 months, or previous liver biopsy confirming chronic HBV infection; Receiving stable nucleos(t)ide analogue (NA) therapy at screening, with no planned changes to NA regimen during the trial; Serum ALT ≤ 2 × ULN at screening; HBeAg, HBV DNA and HBsAg levels meet protocol-specified criteria; Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation.

Exclusion: 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); Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening; History of alcohol abuse within 6 months before screening (14 alcohol units per week: 1 unit = 285 mL beer with ~3.5% alcohol, or 25 mL spirits with ~40% alcohol, or 100 mL wine with ~10% alcohol), or positive breath alcohol test at screening; Vaccination administered within 1 month before screening, or planned vaccination during the trial period; Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period; Participation in any clinical trial with an investigational medicinal product/investigational device within 3 months before screening or within 5 half-lives (whichever is longer); Major trauma or major surgery within 3 months before screening; or planned surgery during the trial period that may impair trial compliance or safety assessment as assessed by the Investigator; Prior solid organ or bone marrow transplantation; Use of systemic immunosuppressants within 3 months before the first dose of investigational product [short-term (≤7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune diseases excluded]; use of immunomodulators or cytotoxic agents within 6 months before the first dose of investigational product; Receipt of any oligonucleotide or small interfering RNA (siRNA) therapy within 12 months before the first dose of investigational product; Coexisting indication for anticoagulant therapy or anticipated requirement for anticoagulation during the trial; Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening; History of alcohol abuse within 6 months before screening, or positive breath alcohol test at screening; Vaccination administered within 1 month before screening, or planned vaccination during the trial period; Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period; Participation in any clinical trial with an investigational medicinal product/investigational device within 3 months before screening or within 5 half-lives (whichever is longer); 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); Positive HBsAg, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening; History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening; Any other condition deemed unsuitable for trial participation by the Investigator; Part 2：; Uncontrolled and clinically significant abnormalities other than chronic HBV infection, such as acute cerebrovascular disease, severe or unstable cardiac disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled dyslipidemia, etc; History of other clinically significant liver diseases; History of liver cirrhosis or progressive liver fibrosis; or liver stiffness measurement (LSM) ≥ 8.5 kPa at screening; Alpha-fetoprotein > 50 ng/mL, or imaging suggestive of possible malignant hepatic lesions; History of extrahepatic diseases potentially related to HBV immune status; History of vasculitis; or signs/symptoms suggestive of underlying vasculitis; or past/current other diseases potentially associated with vasculitic disorders; Active infection requiring systemic antiviral or antibacterial treatment at screening, excluding HBV infection; History of malignant tumors within 5 years before screening, except for specific curable cancers resected surgically; 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 drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening; Any other condition deemed unsuitable for trial participation by the Investigator; Vital signs or laboratory examinations at screening meet the exclusion cut-off values specified in the protocol; QTcF interval (QT corrected by Fridericia's formula) > 450 ms at screening; Female participants who are breastfeeding or have a positive serum pregnancy test at screening; Any of the following laboratory results at screening, or other clinically significant abnormalities rendering the participant unsuitable for trial participation:; Platelet count < 125 × 10\^9/L Absolute neutrophil count < 1.5 × 10\^9/L Hemoglobin < 100 g/L Total bilirubin > 1.25 × ULN Serum albumin < 35 g/L Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m\^2 (calculated using the CKD-EPI formula) Prothrombin time international normalized ratio (INR) > 1.25 Positive hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody; QTcF interval (QT corrected by Fridericia's formula) > 450 ms at screening, or other clinically significant electrocardiogram abnormalities identified at screening; Female participants who are breastfeeding or have a positive serum pregnancy test at screening; Part 1:; Past or current manifestations of hepatic decompensation.

ClinicalTrials.gov NCT07741461