Chronic Hepaititis BPhase 1NCT07741461
ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)
A Phase 1 study testing ACT201 Injection in people with Chronic Hepaititis B, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepaititis B
- What is being tested?
- ACT201 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Part 2：
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Jing Zhang, Ph.D., 021-52887926, Zhangj_fudan@163.com
Wenhong Zhang, Ph.D., 18121186602, zhangwenhong@fudan.edu.cn
About this study
Official title: 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.
- Conditions
- Chronic Hepaititis B
- Being tested
- ACT201 Injection, ACT201 Injection Placebo
- Keywords
- Chronic Hepaititis B, ACT201 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT201 InjectionDrug
Part 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 PlaceboDrug
Part 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.
| Study group | Role | What they receive |
|---|---|---|
| ACT201 Injection group | Experimental | Not described Receives: Drug: ACT201 Injection |
| ACT201 Injection Placebo | Placebo comparator | Not described Receives: Drug: ACT201 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: throughout the full study period,an average of 4 months
Secondary outcomes (24)
Plasma drug concentrations in healthy participants and participants withCHB
Measured: 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）
Measured: throughout the full study period,an average of 4 months
Area Under the Concentration-Time Curve from time zero to infinity（AUC₀-∞）
Measured: throughout the full study period,an average of 4 months
Apparent Volume of Distribution（Vd/F）
Measured: throughout the full study period,an average of 4 months
First-order Elimination Rate Constant(Kel)
Measured: throughout the full study period,an average of 4 months
Elimination Half-life(t₁/₂)
Measured: throughout the full study period,an average of 4 months
Mean Residence Time(MRT)
Measured: throughout the full study period,an average of 4 months
Apparent Clearance(CL/F)
Measured: throughout the full study period,an average of 4 months
Minimum Plasma Concentration at Steady State(Cₘᵢₙ,ₛₛ)
Measured: throughout the full study period,an average of 4 months
Maximum Plasma Concentration at Steady State(Cₘₐₓ,ₛₛ)
Measured: throughout the full study period,an average of 4 months
Average Plasma Concentration at Steady State(Cₐᵥ,ₛₛ)
Measured: 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)
Measured: throughout the full study period,an average of 4 months
Degree of Fluctuation (DF)
Measured: throughout the full study period,an average of 4 months
Accumulation Factor (Rac)
Measured: throughout the full study period,an average of 4 months
Urinary Concentration
Measured: throughout the full study period,an average of 4 months
Cumulative Amount Excreted in Urine
Measured: throughout the full study period,an average of 4 months
Cumulative Percentage of Dose Excreted in Urine
Measured: throughout the full study period,an average of 4 months
Renal Clearance(CL)
Measured: throughout the full study period,an average of 4 months
HBsAg and HBsAb levels and changes from baseline among participants with CHB
Measured: throughout the full study period,an average of 4 months
HBsAg seroclearance rate among participants with CHB
Measured: throughout the full study period,an average of 4 months
HBsAg seroconversion rate among participants with CHB
Measured: throughout the full study period,an average of 4 months
Placebo-corrected baseline-adjusted ΔQTc (ΔΔQTc) among healthy participants
Measured: throughout the full study period,an average of 4 months
Anti-drug antibody (ADA) positive rate among healthy participants and participants with CHB
Measured: throughout the full study period,an average of 4 months
Antibody titers among healthy participants and participants with CHB
Measured: throughout the full study period,an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start6 Aug 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepaititis BStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Ph.D., Principal investigator, Huashan HospitalWenhong Zhang, Ph.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741461
- Sponsor's protocol ID
- ACT201-4-1-001
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07741461
- Acronym / sponsor ID
- ACT201-4-1-001
- Conditions
- Chronic Hepaititis B
- Keywords
- Chronic Hepaititis B, ACT201 Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT201 Injection group | Experimental | Drug: ACT201 Injection |
| ACT201 Injection Placebo | Placebo comparator | Drug: ACT201 Injection Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT201 InjectionPart 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. | Drug | ACT201 Injection group |
| ACT201 Injection PlaceboPart 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. | Drug | ACT201 Injection Placebo |
Primary outcome
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).
24 secondary outcomes
Plasma drug concentrations in healthy participants and participants withCHB
Time frame: 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）
Time frame: throughout the full study period,an average of 4 months
Area Under the Concentration-Time Curve from time zero to infinity（AUC₀-∞）
Time frame: throughout the full study period,an average of 4 months
Apparent Volume of Distribution（Vd/F）
Time frame: throughout the full study period,an average of 4 months
First-order Elimination Rate Constant(Kel)
Time frame: throughout the full study period,an average of 4 months
Elimination Half-life(t₁/₂)
Time frame: throughout the full study period,an average of 4 months
Mean Residence Time(MRT)
Time frame: throughout the full study period,an average of 4 months
Apparent Clearance(CL/F)
Time frame: throughout the full study period,an average of 4 months
Minimum Plasma Concentration at Steady State(Cₘᵢₙ,ₛₛ)
Time frame: throughout the full study period,an average of 4 months
Maximum Plasma Concentration at Steady State(Cₘₐₓ,ₛₛ)
Time frame: throughout the full study period,an average of 4 months
Average Plasma Concentration at Steady State(Cₐᵥ,ₛₛ)
Time frame: 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)
Time frame: throughout the full study period,an average of 4 months
Degree of Fluctuation (DF)
Time frame: throughout the full study period,an average of 4 months
Accumulation Factor (Rac)
Time frame: throughout the full study period,an average of 4 months
Urinary Concentration
Time frame: throughout the full study period,an average of 4 months
Cumulative Amount Excreted in Urine
Time frame: throughout the full study period,an average of 4 months
Cumulative Percentage of Dose Excreted in Urine
Time frame: throughout the full study period,an average of 4 months
Renal Clearance(CL)
Time frame: throughout the full study period,an average of 4 months
HBsAg and HBsAb levels and changes from baseline among participants with CHB
Time frame: throughout the full study period,an average of 4 months
HBsAg seroclearance rate among participants with CHB
Time frame: throughout the full study period,an average of 4 months
HBsAg seroconversion rate among participants with CHB
Time frame: throughout the full study period,an average of 4 months
Placebo-corrected baseline-adjusted ΔQTc (ΔΔQTc) among healthy participants
Time frame: throughout the full study period,an average of 4 months
Anti-drug antibody (ADA) positive rate among healthy participants and participants with CHB
Time frame: throughout the full study period,an average of 4 months
Antibody titers among healthy participants and participants with CHB
Time frame: throughout the full study period,an average of 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Zhang, Ph.D. principal investigator
Huashan Hospital
Wenhong Zhang, Ph.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT201 Injection in people with Chronic Hepaititis B, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang, Ph.D. (021-52887926, Zhangj_fudan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.