ABI-1179
DrugOnce daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
NCT Number: NCT06698575
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Momentum Sunshine, Melbourne, Au, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Part A: Inclusion Criteria:
Part B: Inclusion Criteria:
Part A and B: Exclusion Criteria:
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Up to 56 days after last dose.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing.
Time frame: MAD Cohorts At pre-specified timepoints from Days 8 to 36
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Assembly Biosciences
Industry
A Phase 1a/1b, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple Ascending Doses of ABI-1179 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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