Phase
Condition
Herpes Simplex Infections
Genital Herpes
Treatment
ABI-1179
ABI-1179 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 condition known to interfere with the absorption /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,whatever is longer.
Study Design
Connect with a study center
Momentum Sunshine
Melbourne, Au 3021
AustraliaSite Not Available
East Sydney Doctors
Darlinghurst, 2010
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, 3050
AustraliaSite Not Available
Taylor Square Private Clinic
Surry Hills, 2010
AustraliaSite Not Available
Momentum Clinical Research
Sydney, 2010
AustraliaSite Not Available
Pacific Clinical Research Network
Hamilton, New 3200
New ZealandSite Not Available
New Zealand Clinical Research
Auckland, 1010
New ZealandActive - Recruiting
New Zealand Clinical Research
Christchurch, 8011
New ZealandSite Not Available
Pacific Clinical Research Network
Nelson, 7011
New ZealandSite Not Available
Momentum Palmerston North
Palmerston North, 4414
New ZealandSite Not Available
Pacific Clinical Research Network
Rotorua, 3010
New ZealandSite Not Available
Pacific Clinical Research Network
Upper Hutt, 5018
New ZealandSite Not Available
Momentum Kapiti
Waikanae, 5036
New ZealandSite Not Available
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