A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 with Recurrent Genital Herpes
Phase 1
Recruiting
- Conditions
- Recurrent Genital Herpes Simplex Type 2
- Interventions
- Drug: ABI-5366 Placebo
- Registration Number
- NCT06385327
- Lead Sponsor
- Assembly Biosciences
- Brief Summary
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 146
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 at Screening 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 laboratory results.
- Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 (predose)
- Agreement to comply with protocol-specified contraceptive requirements
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 the results of the study, pose an additional risk in administering study drug to the subject, or a 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 to Screening
- Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before Screening, whichever is longer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: SAD Cohorts 1-5, ABI-5366 ABI-5366 Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5 Part A: SAD Cohorts 1-5, ABI-5366 ABI-5366 Placebo Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5 Part A: SAD Cohorts 1-5, Placebo ABI-5366 Placebo Single dose of matching placebo (tablet) in Part A for Cohorts 1-5 Part A: SAD Fed Cohort 6, ABI-5366 ABI-5366 Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect Part B: MAD Cohorts 1-4 ABI-5366 ABI-5366 Placebo Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose. Part B: MAD Cohorts 1-4 Placebo ABI-5366 Placebo Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose. Part A: SAD Cohorts 1-5, Placebo ABI-5366 Single dose of matching placebo (tablet) in Part A for Cohorts 1-5 Part B: MAD Cohorts 1-4 ABI-5366 ABI-5366 Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose. Part B: MAD Cohorts 1-4 Placebo ABI-5366 Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose.
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Maximum Observed Plasma Concentration (Cmax) of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Apparent Volume of Distribution (Vz/F) of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Time to Cmax (Tmax) of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Apparent Systemic Clearance (CL/F) of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Dose normalized AUCs and Cmax of ABI-5366 SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results Up to 98 days after last dose
- Secondary Outcome Measures
Name Time Method MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained) MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in lesion duration during the swabbing period across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: Difference in lesion rate during the swabbing period across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses MAD Cohorts: At pre-specified time points from Days 8 to 36. MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments MAD Cohorts: At pre-specified time points from Days 8 to 36.
Trial Locations
- Locations (8)
Sutherland Shire Clinical Research
🇦🇺Miranda, New South Wales, Australia
Momentum Clinical Research
🇦🇺Sydney, New South Wales, Australia
Northern Beaches Clinical Research
🇦🇺Sydney, New South Wales, Australia
Wollongong Clinical Research
🇦🇺Wollongong, New South Wales, Australia
Gold Coast Sexual Health Centre
🇦🇺Southport, Queensland, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
New Zealand Clinical Research
🇳🇿Auckland, New Zealand
New Zealand Clinical Research Christchurch
🇳🇿Christchurch, New Zealand