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New treatment option for Chronic Hepatitis B Infection
Official title A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants
ClinicalTrials.gov ID: NCT07511218
What this study is testing
What is AHB-171 Injection?
AHB-171 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic hepatitis b infection.
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
- The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.
- Phase 1: an early, usually small safety study
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
- Healthy Participants:
- Male or female participants, aged 18-55 years old (inclusive);
- Body mass index between 18.0 and 28.0 kg/m\^2 (inclusive);
- Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior...
- Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to...
You likely can't join if
- Healthy Participants:
- Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
- Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within...
- Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.
- Allergy to any investigational drug component.
- Heavy Smoking (\> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing.
See the full eligibility criteria
- Healthy Participants:
- Male or female participants, aged 18-55 years old (inclusive);
- Body mass index between 18.0 and 28.0 kg/m\^2 (inclusive);
- Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal...
- Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs...
- Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6...
- CHB Participants:
- Male or female participants, aged 18-65 years old (inclusive);
- Body mass index between 18.0 and 32.0 kg/m\^2 (inclusive);
- Participants who take effective contraceptive measures as required;
- HBsAg \> 100 IU/mL and ≤ 3000 IU/mL, and HBV DNA \< 100 IU/mL at screening.
- Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening.
- Healthy Participants:
- Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
- Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months.
- Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.
- Allergy to any investigational drug component.
- Heavy Smoking (\> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing.
- Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.
- Abdominal skin issues that may affect drug injection/observation.
- Positive for HBV, HCV, HIV, or syphilis.
- Clinically significant ECG abnormality or TdP risk factors.
- Any condition judged unsuitable by investigator.
- CHB Participants:
- Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
- Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices.
- History or suspicion of hepatocellular carcinoma (HCC); AFP \> 50 ng/mL.
- Diagnosed or Suspected cirrhosis within 12 months.
- History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV).
- Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months.
- Major injury/surgery within 6 months, planned surgery during study, or acute infection within 14 days.
- Allergy to any investigational drug component.
- Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.
- Abdominal skin issues that may affect drug injection/observation.
- Key laboratory result not suitable for clinical trial.
- HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E.
- Clinically significant ECG abnormality or TdP risk factors.
- Any condition judged unsuitable by investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Ch’ang-ch’un, Jilin, China
- Hangzhou, Zhejiang, 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 - 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?
Study sites include Ch’ang-ch’un, Jilin, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.