Phase
Condition
Hepatitis B
Treatment
Placebo
IB-001
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to provide written informed consent.
Male or female aged 18 to 70 years.
Females must not be of childbearing potential OR those who are of childbearingpotential must be non-pregnant and non-lactating and willing to use a highlyeffective method of contraception. Males whose partners are of childbearing potential must either be surgically sterileor willing to use a highly effective acceptable method of contraception.
Non-tattooed, clear injection site suitable for SC injection and monitoring in theopinion of the Investigator.
Exclusion
Exclusion Criteria:
Healthy participants must not meet any of the following criteria at Screening or upon admission to the site (on Day -1).
Major surgery requiring general anesthesia within 12 weeks prior to Screening or isexpected to have surgery requiring general anesthesia during the course of thestudy.
History of severe allergic or anaphylactic reactions, or sensitivity to the IP orits constituents.
Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeksbefore Screening or plasma donations within 7 days prior to dosing on Study Day 1.
Any underlying medical condition (including but not limited to gastrointestinal,renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary,immune, mental, or cardiovascular and cerebrovascular diseases).
History of malignancy, except for non-melanoma skin cancer, excised more than 1 yearprior to Screening or cervical intraepithelial neoplasia that has been successfullycured more than 5 years prior to Screening.
Current hepatitis A virus (HAV) infection, hepatitis B virus (HBV) infection ,hepatitis C virus (HCV) infection , or hepatitis E virus (HEV) infection .Positivetest for HIV-1 or HIV-2 antibodies.
Any other active infection requiring systemic antiviral or antimicrobial therapythat will not be completed within 2 weeks of first dosing.
Clinically significant 12-lead ECG abnormalities on Screening ECG.
History of cardiac arrhythmias.
Physical examination findings at Screening that are considered clinicallysignificant by the Investigator and likely to adversely impact study conduct and/orinterpretation.
Clinically significant abnormal vital signs
Laboratory examination abnormalities considered clinically significant by theInvestigator at Screening.
Use of any prescribed or over-the-counter medications (including vitamins or herbalremedies) within 2 weeks of first dosing or within 5 times the elimination half-lifeof the medication prior to first dosing.
Any suspicion or history of drug and/or alcohol abuse within the last year.
Pregnant, planning to become pregnant during the course of the study, or currentlybreastfeeding.
Study Design
Study Description
Connect with a study center
New Zealand Clinical Research
Auckland, Auckland 1010
New ZealandActive - Recruiting
New Zealand Clinical Research
Auckland 2193733, 1010
New ZealandSite Not Available

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