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This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 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-1179 | Experimental | Single dose of ABI-1179 (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 or 7, ABI-1179 | Experimental | Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect |
|
| Part B: MAD Cohorts 1-4, ABI-1179 | Experimental | Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose. |
|
| Part B: MAD Cohorts 1-4 Placebo | Placebo Comparator | Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-1179 | Drug | Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve, (AUC) of ABI-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing. | |
| Time to Cmax (Tmax) of ABI-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 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) ABI-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179 | SAD Cohorts: before and at pre-specified timepoints up to 144 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 between fasted and fed treatments | MAD Cohorts: At pre-specified time points from Days 8 to 36. | |
| SAD Cohorts: Comparison of plasma Cmax between fasted and fed treatments | SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. |
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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 |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research | Kansas City | Missouri | 64114 | United States | ||
| Rochester Clinical Research |
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| ABI-1179 Placebo | Drug | Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD) |
|
| Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AE's and abnormal laboratory results. | Up to 56 days after last dose. |
| MAD Cohort: If applicable comparison of plasma AUC and Cmax with and without loading doses | MAD Cohorts At pre-specified timepoints 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: 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>4log10 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 the 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 the 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 the 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. |
| Rochester |
| New York |
| 14609 |
| United States |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | United States |
| University of Washington Virology Research Clinic | Seattle | Washington | 98104 | United States |
| East Sydney Doctors | Darlinghurst | Australia | 2010 | Australia |
| Royal Melbourne Hospital | Parkville | Australia | 3050 | Australia |
| Taylor Square Private Clinic | Surry Hills | Australia | 2010 | Australia |
| Momentum Clinical Research | Sydney | Australia | 2010 | Australia |
| Canopy Clinical Wollongong | Wollongong | Australia | 2500 | Australia |
| Momentum Sunshine | Melbourne | Au | 3021 | Australia |
| New Zealand Clinical Research | Auckland | New Zealand | 1010 | New Zealand |
| New Zealand Clinical Research | Christchurch | New Zealand | 8011 | New Zealand |
| Pacific Clinical Research Network | Nelson | New Zealand | 7011 | New Zealand |
| Momentum Palmerston North | Palmerston North | New Zealand | 4414 | New Zealand |
| Pacific Clinical Research Network | Rotorua | New Zealand | 3010 | New Zealand |
| Pacific Clinical Research Network | Upper Hutt | New Zealand | 5018 | New Zealand |
| Momentum Kapiti | Waikanae | New Zealand | 5036 | New Zealand |
| Pacific Clinical Research Network | Hamilton | New | 3200 | 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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