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Tests treatment safety and results for Chronic Hepatitis B Infection
Official title A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
ClinicalTrials.gov ID: NCT07059403
What this study is testing
What is SN2001?
SN2001 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic hepatitis b infection.
Also referred to as Placebo.
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 is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.
- 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 55, men only. Healthy volunteers may be eligible.
You may be able to join if
- Age 18 to 55 years, inclusive.
- Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2.
- Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs...
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral...
- Women of childbearing potential (WOCBP) may be enrolled in the study if the participant:
You likely can't join if
- History of Hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens.
- Clinical laboratory evidence of active infection with human immunodeficiency virus (HIV) infection, or hepatitis C virus (HCV) infection, or...
- Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks.
- History of HBV vaccination:
- Have not previously been vaccinated in the community for Hepatitis B (Engerix-B or similar), or
- Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) and a seroprotective Hepatitis B surface...
See the full eligibility criteria
Who can join
- Age 18 to 55 years, inclusive.
- Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2.
- Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post-menopause. A postmenopausal state should be confirmed...
- Women of childbearing potential (WOCBP) may be enrolled in the study if the participant:
- has practiced highly-effective contraception for 28 days prior to first injection, and
- has a negative pregnancy test at Screening, and
- agrees to refrain from ova donation from Screening until 48 weeks after completion of the final injection, and
- practices abstinence as part of her usual and preferred lifestyle, and
- has agreed to continue highly-effective contraception from Screening until 48 weeks after completion of the final injection.
- Male participants:
- with documented bilateral orchiectomy, or
- agrees to practice abstinence from penile-vaginal intercourse or use condoms from Screening until 48 weeks after completion of the final subcutaneous injection, and
- agrees to refrain from sperm donation from Screening until 48 weeks after completion of the final injection, and
- the highly effective contraceptive methods listed above should also apply to WOCBP partners of male participants for the specified duration, in addition to male condom use, from Screening until 48 weeks after completion...
- Willing to comply with the study requirements and to provide written informed consent.
What rules you out
- History of Hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens.
- Clinical laboratory evidence of active infection with human immunodeficiency virus (HIV) infection, or hepatitis C virus (HCV) infection, or hepatitis A virus (HAV), or hepatitis D virus (HDV), or syphilis and/or any...
- Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks.
- History of HBV vaccination:
- Have not previously been vaccinated in the community for Hepatitis B (Engerix-B or similar), or
- Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) and a seroprotective Hepatitis B surface antibody (HBsAb) titre \<10 milli-international units per milliliter...
- Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) within 6 months prior to the screening visit, or
- Have HBV vaccination scheduled plan within 48 weeks after the final study drug dosing.
- Receipt of any investigational drug or vaccine or medical device clinical trial within 3 months or 5 half-lives (whichever is greater) prior to screening.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin greater than or equal to 1.5×ULN, or any other laboratory values considered clinically significant abnormalities and unacceptable by...
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude including (but not limited to) neurological disease, cardiovascular disease, hepatic or...
- History of Cancer within 3 years, excluding basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia, which is cured is allowed.
- Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus.
- History of any severe trauma or major surgical condition within 3 months or planned to undergo surgery during the study period.
- Presently receiving (or history of receiving), during the preceding 3 months or 5 half-lives (whichever is greater), any medications or other treatments that may adversely affect the immune system such as allergy...
- Used prescription drugs or vaccines within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- Used over-the-counter (OTC) medication or herbal supplements, excluding routine vitamins, within 7 days before the first dose of study drug, unless determined by the Investigator and the Sponsor to be not clinically...
- Participants smoke ≥ 10 cigarettes a day within 3 months before screening, or those who cannot stop using any tobacco products from screening until 24 weeks after the final injection.
- History or clinical evidence of alcohol abuse, within the 3 months before screening, and unwillingness to abstain from alcohol within 3 weeks after the final study drug dosing. Alcohol abuse is defined as regular weekly...
- History or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to...
- Confirmed positive results from drug of abuse (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, cotinine...
- History of significant local or systemic reactogenicity (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration).
- Donated more than 400 mL of blood within 30 days before the first dose of study drug.
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Herston, Queensland, Australia
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 male, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herston, Queensland, Australia. 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.