ABI-5366
DrugOnce daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)
NCT Number: NCT06385327
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 1
East Sydney Doctors, Darlinghurst, New South Wales, 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 or monthly tablet dosing over the 29-day treatment period (MAD)
Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Up to 98 days after last dose
Time frame: SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing.
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.
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-5366 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.
Published trials that share one or more normalized conditions with this study.
NCT06698575
Communicable Diseases, DNA Virus Infections
Kansas City, Missouri, United States
View Trial DetailsNCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial DetailsNCT06033261
Communicable Diseases, DNA Virus Infections
Birmingham, Alabama, United States
View Trial DetailsNCT05298254
Communicable Diseases, DNA Virus Infections
Phoenix, Arizona, United States
View Trial Details