ACT201 Injection in Participants With Chronic Hepatitis B (CHB) on Nucleos(t)Ide Analog Therapy - Phase Ib

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is a multicenter, randomized, open-label, parallel-controlled Phase Ib clinical trial. It aims to evaluate the safety and preliminary efficacy of ACT201 Injection combined with standard therapy (PegIFNα, NA) in participants with chronic hepatitis B who are receiving NA treatment. A total of 40 participants with chronic hepatitis B will be enrolled. Eligible participants should have stable NA treatment, HBV DNA \< 100 IU/mL, negative HBeAg, and HBsAg ≤ 100 IU/mL. They will be randomized into four treatment groups at a 1:1:1:1 ratio.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Voluntarily participate in this trial and sign the informed consent form;
• Aged 18 to 65 years (inclusive), male or female;
• Body mass index (BMI) ranging from 18 to 32 kg/m² (inclusive);
• HBsAg-positive or HBV DNA-positive for at least 6 months, or with prior liver biopsy results consistent with chronic HBV infection, or HBsAg-positive and anti-HBc IgM-negative at screening;
• Receiving stable nucleos(t)ide analogue (NA) therapy at screening;
• Meeting the specified requirements for HBsAg, HBeAg, HBV DNA and liver function parameters;
• Willing to use effective contraception with no plan to conceive, donate sperm or donate ova.

Exclusion Criteria:

• Subjects who have sustained major trauma or undergone major surgery recently, or have a planned surgery;
• Subjects with uncontrolled, clinically significant abnormalities or other severe illnesses in addition to chronic HBV infection;
• Subjects with a history of other liver diseases;
• Subjects with a history of liver cirrhosis;
• Subjects with imaging findings suggestive of a suspected malignant hepatic lesion;
• Subjects with prior or current manifestations of hepatic decompensation;
• Subjects with a history of extrahepatic diseases potentially associated with HBV immune status;
• Subjects with other diseases associated with vasculitis;
• Subjects with infections (other than HBV) requiring systemic antiviral or antibacterial therapy at screening;
• Subjects with a history of malignancy;
• Subjects with prior solid organ or bone marrow transplantation;
• Subjects with current or past history of severe psychiatric disorders;
• Subjects with severe retinopathy or other severe ophthalmologic diseases;
• Subjects who have received prohibited study drugs previously or currently;
• Subjects with concomitant hematological diseases;
• Subjects with abnormal laboratory findings;
• Subjects with abnormal QTcF interval;
• Subjects with a history of allergy;
• Subjects who are breastfeeding or have a positive serum pregnancy test at screening;
• Subjects participating in another clinical trial, or those who have not completed the washout period specified in the protocol prior to this trial;
• Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in this trial.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (4)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

4 locations

Study team and timeline

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Study start

Nov 20, 2026 Estimated

Primary completion

2027-02 Estimated

Study completion

2027-12 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts