A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
ConditionChronic Hepatitis B Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorChimivac INC
About this trial
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.
Eligibility criteria
Qualifiers
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 by at least 12 months since last menstrual period and FSH > 40 IU.
Disqualifiers
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 other chronic viral infection.
Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks.
Have not previously been vaccinated in the community for Hepatitis B (Engerix-B or similar), or
Trial design
Treatments tested in this trial
- SN2001
- SN2001
- SN2001
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov