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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-5366 | Experimental | Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5 |
|
| Part A: SAD Cohorts 1-5, Placebo | Placebo Comparator | Single dose of matching placebo (tablet) in Part A for Cohorts 1-5 |
|
| Part A: SAD Fed Cohort 6, ABI-5366 | Experimental | Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect |
|
| Part B: MAD Cohorts 1-4 ABI-5366 | Experimental | 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 | Placebo Comparator | Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-5366 | Drug | Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| 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. | |
| 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 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. | |
| 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. | |
| 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. | |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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: If applicable, comparison of plasma PK profiles and parameters with and without loading doses |
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Part A: Inclusion Criteria:
Part B: Inclusion Criteria:
Part A and B: Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Sydney Doctors | Darlinghurst | New South Wales | 2010 | Australia | ||
| Canopy Clinical Sutherland |
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| ABI-5366 Placebo | Drug | Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) |
|
| Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results | Up to 98 days after last dose |
| MAD Cohorts: At pre-specified time points from Days 8 to 36. |
| 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 rate during the swabbing period 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. |
| 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. |
| Miranda |
| New South Wales |
| 2228 |
| Australia |
| Momentum Clinical Research | Sydney | New South Wales | 2010 | Australia |
| Canopy Beaches Clinical Research | Sydney | New South Wales | 2100 | Australia |
| Canopy Clinical Wollongong | Wollongong | New South Wales | 2500 | Australia |
| Momentum Sunshine | Melbourne | Victoria | 3021 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| New Zealand Clinical Research | Auckland | 1010 | New Zealand |
| New Zealand Clinical Research Christchurch | Christchurch | 8011 | New Zealand |
| Pacific Clinical Research Network - Hamilton | Hamilton | 3200 | New Zealand |
| Pacific Clinical Research Network - Tasman | Nelson | 7011 | New Zealand |
| Momentum Palmerston North | Palmerston North | 4414 | New Zealand |
| Pacific Clinical Research Network - Rotorua | Rotorua | 3010 | New Zealand |
| Pacific Clinical Research Network - Wellington | Upper Hutt | 5018 | New Zealand |
| Momentum Kapiti | Waikanae | 5036 | New Zealand |
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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