Actively Recruiting
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
Led by Chimivac INC · Updated on 2025-08-24
36
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2.
- In good general health based on medical evaluation including history, vital signs, physical exam, ECG, and lab tests.
- Female participants must be of non-childbearing potential or meet strict contraception requirements.
- Male participants must agree to practice abstinence or use condoms and avoid sperm donation during and after the study.
- Willing to comply with study requirements and provide written informed consent.
You will not qualify if you...
- History of Hepatitis B virus infection.
- Active infection with HIV, hepatitis C, A, D, syphilis, or other chronic viral infections.
- Known exposure to Hepatitis B virus within the past 6 weeks.
- Prior Hepatitis B vaccination with certain conditions or planned vaccination during study.
- Participation in other investigational drug, vaccine, or device trials within 3 months.
- Elevated liver enzymes or clinically significant abnormal lab values.
- History of significant medical illness including neurological, cardiovascular, hepatic, renal, gastrointestinal, respiratory, metabolic, or skeletal diseases.
- History of cancer within 3 years except certain cured skin or cervical conditions.
- Conditions causing impaired immune response including diabetes.
- Recent severe trauma or major surgery.
- Recent or current use of medications affecting the immune system, excluding some corticosteroids.
- Recent use of prescription drugs or vaccines.
- Recent use of over-the-counter medications or herbal supplements except routine vitamins or certain pain relievers.
- Smoking 10 or more cigarettes daily within 3 months or inability to stop tobacco use during study.
- History or evidence of alcohol abuse or unwillingness to abstain post dosing.
- History or evidence of drug abuse.
- Positive drug or alcohol test at screening.
- History of severe allergic or injection site reactions.
- Recent significant blood donation.
- Any condition deemed unsuitable by the investigator for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
C
Clinical Development VP, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here