Phase 1 Hepatitis B Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For healthy participants:
- Men or women between 18 and 55 years old.
- Body weight in a healthy range, with a BMI between 18.0 and 28.0 (confirm with trial site for exact measurement).
- Routine health checks done during screening — including blood tests, heart tracing (ECG), and scans — are found to be normal or not medically concerning by the doctor running the trial.
- Women who could become pregnant must have a negative pregnancy test at screening, not be pregnant or breastfeeding, and must agree to use effective contraception and not donate eggs from the start of the study until 6 months after the last dose.
- Men must agree to use highly effective contraception to protect any female partner who could become pregnant, and must not donate sperm from the start of the study until 6 months after the last dose.
- Liver and kidney function test results meet the required levels at screening.
For people with chronic hepatitis B (CHB):
- Men or women between 18 and 65 years old.
- BMI between 18.0 and 32.0 (confirm with trial site for exact measurement).
- Agreement to use effective contraception as required by the trial.
- Specific hepatitis B blood marker (HBsAg) levels fall within a defined range, and the amount of hepatitis B virus in the blood is below a certain level at screening (confirm with trial site for exact values).
- Currently on stable antiviral treatment (called NA therapy) for at least 6 months, and on the same medication without change for at least 3 months before screening.
Who may not be able to join:
For healthy participants:
- Currently taking part in another clinical study, or having received an experimental medicine within 3 months or 5 half-lives of the last dose (whichever is longer).
- Having a significant ongoing health condition such as heart, nerve, kidney, immune, or metabolic disease, or any history of cancer.
- Having had major surgery or a serious injury in the past 6 months.
- Having had an acute illness such as flu or stomach infection in the past 14 days, or a vaccination in the past 28 days before screening.
- Known allergy to any ingredient in the study drug.
- Smoking more than 5 cigarettes a day, a history of drug or alcohol misuse, or having consumed caffeine or alcohol in the 48 hours before taking the study drug.
- Having donated or lost 400 mL or more of blood, or received a blood transfusion, in the past 12 weeks, or planning to donate blood during the study.
- Skin problems on the abdomen that could affect how the study drug is injected or monitored.
- Testing positive for hepatitis B, hepatitis C, HIV, or syphilis.
- Having a heart rhythm problem on the ECG, or risk factors for a specific type of dangerous heart rhythm (TdP) (confirm with trial site).
- Any other condition the trial doctor considers makes participation unsuitable.
For people with chronic hepatitis B (CHB):
- Currently taking part in another clinical study, or having received an experimental medicine within 3 months or 5 half-lives of the last dose (whichever is longer).
- Having fluid build-up in the abdomen, gastrointestinal bleeding, confusion caused by liver disease, or enlarged veins in the oesophagus.
- A confirmed or suspected diagnosis of liver cancer, or a specific liver marker (AFP) above 50 ng/mL at screening.
- A diagnosis or suspicion of liver scarring (cirrhosis) within the past 12 months.
- A history of organ transplantation, autoimmune disease, or other serious long-term illness beyond chronic hepatitis B.
- Having used certain gene-silencing or oligonucleotide-based therapies (such as ASO or siRNA treatments), or interferon, within the past 12 months.
- Having had a major injury or surgery in the past 6 months, planned surgery during the study, or an acute infection in the past 14 days.
- Known allergy to any ingredient in the study drug.
- Having donated or lost 400 mL or more of blood, or received a blood transfusion, in the past 12 weeks, or planning to donate blood during the study.
- Skin problems on the abdomen that could affect how the study drug is injected or monitored.
- Key blood or laboratory test results that are not suitable for a clinical trial (confirm with trial site).
- Testing positive for HIV, hepatitis C, or active syphilis, or having an unresolved hepatitis A, D, or E infection.
- Having a heart rhythm problem on the ECG, or risk factors for a specific type of dangerous heart rhythm (TdP) (confirm with trial site).
- Any other condition the trial doctor considers makes participation unsuitable.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 0571-86959519
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); Change from baseline in laboratory tests; Change from baseline in physical examinations; Change from baseline in vital signs; Change from baseline in electrocardiograms (ECGs); Part A:Plasma Cmax of AHB-171; Part A:Plasma Tmax of AHB-171; Part A Plasma AUC of AHB-171; Part A Plasma t1/2 of AHB-171; Proportion of participants with clinically significant abnormalities in laboratory tests; Proportion of p...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.