HBV Infection study: HECN30227 injection
Official title A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07771140
What this study is testing
What is HECN30227 injection(SAD)?
HECN30227 injection(SAD) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hbv 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
- To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B
- 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
- people must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Male people must weigh at least 50 kg; female people must weigh at least 45 kg.
- Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen...
- Female people of childbearing potential or male people must agree to use effective contraception from the time of signing the informed consent form...
- people must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir...
You likely can't join if
- people who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
- people with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or...
- people with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
- people with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result...
- people who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to...
- people who participated in another clinical trial within 3 months prior to screening.
See the full eligibility criteria
- people must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Male people must weigh at least 50 kg; female people must weigh at least 45 kg.
- Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by...
- Female people of childbearing potential or male people must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug.
- people must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening.
- HBV DNA \< 90 IU/mL at screening.
- HBsAg \> 100 IU/mL at screening.
- Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline.
- people who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
- people with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods).
- people with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
- people with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing.
- people who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening
- people who participated in another clinical trial within 3 months prior to screening.
- people who develop an acute illness (e.g., acute respiratory disease) or receive concomitant medication from the time of signing the informed consent form to prior to the first dose.
- people who are breastfeeding or have a positive serum pregnancy test result.
- people with significant hepatic fibrosis or liver cirrhosis.
- people with a history of hepatic decompensation manifestations or disease at screening or in the past, including but not limited to ruptured esophageal and gastric variceal bleeding, ascites, hepatic encephalopathy, etc.
- people diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present.
- people with international normalized ratio (INR) \>1.5, or platelet count \<90×10⁹/L, or serum albumin \<35 g/L at screening.
- people with alpha-fetoprotein (AFP) \>50 ng/mL at screening.
- people with endogenous creatinine clearance (CLcr) \<60 mL/min/1.73 m² at screening.
- people receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening.
- people whom the investigator considers unsuitable for participation in this trial for any other reasons.
The study team makes the final eligibility decision.
Where it is enrolling
- Hefei, 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 Hefei, 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.