NCT07741461RecruitingPhase 1
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
Xiamen Amoytop Biotech Co., Ltd.1 site in 1 country72 target enrollmentStarted: August 6, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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 Criteria
- •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 ≥ 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.
- •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) ≥ 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 (≤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.
- •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.
- •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).
- •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, 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.
- •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.
Arms & Interventions
ACT201 Injection group
Experimental
Intervention: ACT201 Injection (Drug)
ACT201 Injection Placebo
Placebo Comparator
Intervention: ACT201 Injection Placebo (Drug)
Outcomes
Primary Outcomes
Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Time Frame: throughout the full study period,an average of 4 months
Assessments include vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs).
Secondary Outcomes
- Plasma drug concentrations in healthy participants and participants withCHB(throughout the full study period,an average of 4 months)
- Area Under the Concentration-Time Curve from time zero to the last measurable concentration（AUC₀-ₜ）(throughout the full study period,an average of 4 months)
- Area Under the Concentration-Time Curve from time zero to infinity（AUC₀-∞）(throughout the full study period,an average of 4 months)
- Apparent Volume of Distribution（Vd/F）(throughout the full study period,an average of 4 months)
- First-order Elimination Rate Constant(Kel)(throughout the full study period,an average of 4 months)
- Elimination Half-life(t₁/₂)(throughout the full study period,an average of 4 months)
- Mean Residence Time(MRT)(throughout the full study period,an average of 4 months)
- Apparent Clearance(CL/F)(throughout the full study period,an average of 4 months)
- Minimum Plasma Concentration at Steady State(Cₘᵢₙ,ₛₛ)(throughout the full study period,an average of 4 months)
- Maximum Plasma Concentration at Steady State(Cₘₐₓ,ₛₛ)(throughout the full study period,an average of 4 months)
- Average Plasma Concentration at Steady State(Cₐᵥ,ₛₛ)(throughout the full study period,an average of 4 months)
- Area Under the Concentration-Time Curve over one dosing interval at steady state(AUC₀-τ)(throughout the full study period,an average of 4 months)
- Degree of Fluctuation (DF)(throughout the full study period,an average of 4 months)
- Accumulation Factor (Rac)(throughout the full study period,an average of 4 months)
- Urinary Concentration(throughout the full study period,an average of 4 months)
- Cumulative Amount Excreted in Urine(throughout the full study period,an average of 4 months)
- Cumulative Percentage of Dose Excreted in Urine(throughout the full study period,an average of 4 months)
- Renal Clearance(CL)(throughout the full study period,an average of 4 months)
- HBsAg and HBsAb levels and changes from baseline among participants with CHB(throughout the full study period,an average of 4 months)
- HBsAg seroclearance rate among participants with CHB(throughout the full study period,an average of 4 months)
- HBsAg seroconversion rate among participants with CHB(throughout the full study period,an average of 4 months)
- Placebo-corrected baseline-adjusted ΔQTc (ΔΔQTc) among healthy participants(throughout the full study period,an average of 4 months)
- Anti-drug antibody (ADA) positive rate among healthy participants and participants with CHB(throughout the full study period,an average of 4 months)
- Antibody titers among healthy participants and participants with CHB(throughout the full study period,an average of 4 months)
Investigators
Study Sites (1)
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