Phase
Condition
Genital Herpes
Herpes Simplex Infections
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
East Sydney Doctors
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Canopy Clinical Sutherland
Miranda, New South Wales 2228
AustraliaSite Not Available
Sutherland Shire Clinical Research
Miranda, New South Wales 2228
AustraliaActive - Recruiting
Taylor Square Private Clinic
Surry Hills, New South Wales 2010
AustraliaSite Not Available
Canopy Beaches Clinical Research
Sydney, New South Wales 2100
AustraliaSite Not Available
Momentum Clinical Research
Sydney, New South Wales 2010
AustraliaActive - Recruiting
Northern Beaches Clinical Research
Sydney, New South Wales 2100
AustraliaActive - Recruiting
Canopy Clinical Wollongong
Wollongong, New South Wales 2500
AustraliaSite Not Available
Wollongong Clinical Research
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
East Sydney Doctors
Darlinghurst 2169378, New South Wales 2155400 2010
AustraliaSite Not Available
Canopy Clinical Sutherland
Miranda 2157495, New South Wales 2155400 2228
AustraliaSite Not Available
Canopy Beaches Clinical Research
Sydney 2147714, New South Wales 2155400 2100
AustraliaSite Not Available
Momentum Clinical Research
Sydney 2147714, New South Wales 2155400 2010
AustraliaSite Not Available
Canopy Clinical Wollongong
Wollongong 2171507, New South Wales 2155400 2500
AustraliaSite Not Available
Gold Coast Sexual Health Centre
Southport, Queensland 4215
AustraliaSite Not Available
Momentum Sunshine
Melbourne, Victoria 3021
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaSite Not Available
Momentum Sunshine
Melbourne 2158177, Victoria 2145234 3021
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville 2153770, Victoria 2145234 3050
AustraliaSite Not Available
New Zealand Clinical Research
Auckland, 1010
New ZealandSite Not Available
New Zealand Clinical Research
Auckland 2193733, 1010
New ZealandSite Not Available
New Zealand Clinical Research Christchurch
Christchurch, 8011
New ZealandSite Not Available
New Zealand Clinical Research Christchurch
Christchurch 2192362, 8011
New ZealandSite Not Available
Pacific Clinical Research Network - Hamilton
Hamilton, 3200
New ZealandSite Not Available
Pacific Clinical Research Network - Hamilton
Hamilton 2190324, 3200
New ZealandSite Not Available
Pacific Clinical Research Network - Tasman
Nelson, 7011
New ZealandSite Not Available
Pacific Clinical Research Network - Tasman
Nelson 2186280, 7011
New ZealandSite Not Available
Momentum Palmerston North
Palmerston North, 4414
New ZealandSite Not Available
Momentum Palmerston North
Palmerston North 2185018, 4414
New ZealandSite Not Available
Pacific Clinical Research Network - Rotorua
Rotorua, 3010
New ZealandSite Not Available
Pacific Clinical Research Network - Rotorua
Rotorua 6241325, 3010
New ZealandSite Not Available
Pacific Clinical Research Network - Wellington
Upper Hutt, 5018
New ZealandSite Not Available
Pacific Clinical Research Network - Wellington
Upper Hutt 6244895, 5018
New ZealandSite Not Available
Momentum Kapiti
Waikanae, 5036
New ZealandSite Not Available
Momentum Kapiti
Waikanae 2180320, 5036
New ZealandSite Not Available

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