Chronic Hepaititis B study: ACT201 Injection
Official title ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)
ClinicalTrials.gov ID: NCT07741461
What this study is testing
What is ACT201 Injection?
This is an investigational injectable medicine being studied as a potential treatment for chronic hepatitis B.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check the safety of the injection and see how the body handles it at different doses.
- Who it's for
- The study is looking for healthy adults and adults with chronic hepatitis B whose virus levels are controlled by current medication.
- What's involved
- Participants will receive an injection or a placebo (a shot with no medicine) and undergo regular health checks and blood tests.
- Time commitment
- The study involves multiple visits over a period of time to monitor safety and drug levels.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial...
- 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...
- Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial...
You likely can't join if
- Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged...
- History of clinically significant diseases involving cardiovascular, hematologic and lymphatic, urinary, endocrine, immune, psychiatric, or nervous...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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 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...
What rules you out
- 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...
- 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...
- 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]
- 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 \ 1.25 × ULN Serum albumin \ 1.25 Positive...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.