Phase
Condition
Herpes Simplex Infections
Genital Herpes
Treatment
ABI-5366
ABI-5366 Placebo
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Part A: Inclusion Criteria:
Subject has a body mass index (BMI) between ≥ 18.0 and < 32.0 kg/m2
In good health (as determined by the Investigator) based on medical history,physical examination, ECG, and clinical laboratory results.
Female subjects must be non-pregnant and have a negative serum pregnancy test atScreening and a negative urine pregnancy test at Day -1 or Day 1 (predose)
Agreement to comply with protocol-specified contraceptive requirements
Part B: Inclusion Criteria:
Subject has a body mass index (BMI) between ≥ 18.0 and < 32.0 kg/m2
Other than HSV infection, is in good health (as determined by the Investigator)based on medical history, physical examination, ECG, and clinical laboratoryresults.
Female subjects must be non-pregnant and have a negative serum pregnancy test atScreening and a negative urine pregnancy test at Day 1 (predose)
Agreement to comply with protocol-specified contraceptive requirements
Exclusion
Part A and B: Exclusion Criteria:
Current infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV).
History of any illness that, in the opinion of the Investigator, might confound theresults of the study, pose an additional risk in administering study drug to thesubject, or a condition known to interfere with theabsorption/distribution/elimination of drugs.
History of any significant drug-related allergic reactions such as anaphylaxis,Stevens-Johnson syndrome, urticaria, or multiple drug allergies
History of persistent alcohol abuse or illicit drug abuse within 3 years prior toScreening
Has participated in a clinical study involving administration of either aninvestigational or a marketed drug within 30 days or 5 half-lives before Screening,whichever is longer.
Study Design
Connect with a study center
Sutherland Shire Clinical Research
Miranda, New South Wales 2228
AustraliaActive - Recruiting
Momentum Clinical Research
Sydney, New South Wales 2010
AustraliaActive - Recruiting
Northern Beaches Clinical Research
Sydney, New South Wales 2100
AustraliaActive - Recruiting
Wollongong Clinical Research
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Gold Coast Sexual Health Centre
Southport, Queensland 4215
AustraliaActive - Recruiting
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaActive - Recruiting
New Zealand Clinical Research
Auckland, 1010
New ZealandActive - Recruiting
New Zealand Clinical Research Christchurch
Christchurch, 8011
New ZealandActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.