AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)

RecruitingPhase 1Ages 18 Years - 65 YearsAllXiamen Amoytop Biotech Co., Ltd.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 โ‰ค 2 ร— 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 Criteria: Part 1: * 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). * Positive HBsAg, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening. * QTcF interval (QT corrected by Fridericia's formula) \> 450 ms at screening. * Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening. * History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at 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 โ‰ฅ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period. * Female participants who are breastfeeding or have a positive serum pregnancy test at screening. * 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). * Any other condition deemed unsuitable for trial participation by the Investigator. Part 2๏ผš * 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. * 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) โ‰ฅ 8.5 kPa at screening. * Alpha-fetoprotein \> 50 ng/mL, or imaging suggestive of possible malignant hepatic lesions. * Past or current manifestations of hepatic decompensation. * 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. * Prior solid organ or bone marrow transplantation. * Use of systemic immunosuppressants within 3 months before the first dose of investigational product \[short-term (โ‰ค7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune diseases excluded\]; 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. * Any of the following laboratory results at screening, or other clinically significant abnormalities rendering the participant unsuitable for trial participation: Platelet count \< 125 ร— 10\^9/L Absolute neutrophil count \< 1.5 ร— 10\^9/L Hemoglobin \< 100 g/L Total bilirubin \> 1.25 ร— ULN Serum albumin \< 35 g/L Estimated glomerular filtration
๐Ÿ’Š

What it tests

  • ACT201 Injection
  • ACT201 Injection Placebo
๐Ÿ“

Where

1 site
Huashan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy