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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06385327
Recruitment Status : Not yet recruiting
First Posted : April 26, 2024
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences

Tracking Information
First Submitted Date  ICMJE April 18, 2024
First Posted Date  ICMJE April 26, 2024
Last Update Posted Date April 26, 2024
Estimated Study Start Date  ICMJE May 2024
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2024)
  • Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results [ Time Frame: Up to 70 days after last dose ]
  • Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366 [ 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. ]
  • Maximum Observed Plasma Concentration (Cmax) of ABI-5366 [ 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 to Cmax (Tmax) of ABI-5366 [ 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. ]
  • Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366 [ 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. ]
  • Apparent Systemic Clearance (CL/F) of ABI-5366 [ 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. ]
  • Apparent Volume of Distribution (Vz/F) of ABI-5366 [ 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. ]
  • Dose normalized AUCs and Cmax of ABI-5366 [ 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2024)
  • SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36. ]
  • MAD Cohorts: Difference in lesion rate during the swabbing period across treatments [ Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36. ]
  • MAD Cohorts: Difference in lesion duration during the swabbing period across treatments [ Time Frame: 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 [ Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Genital Herpes Simplex Type 2
Intervention  ICMJE
  • Drug: ABI-5366
    Once daily tablet dosing (SAD) or Weekly tablet dosing over 29 days (MAD)
    Other Name: ABI-5366 SAD
  • Drug: ABI-5366 Placebo
    Once daily tablet dosing (SAD) or Weekly tablet dosing over 29 days (MAD)
    Other Name: ABI-5366 Placebo SAD
Study Arms  ICMJE
  • Experimental: Part A: SAD Cohorts 1-5, ABI-5366
    Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5
    Interventions:
    • Drug: ABI-5366
    • Drug: ABI-5366 Placebo
  • Placebo Comparator: Part A: SAD Cohorts 1-5, Placebo
    Single dose of matching placebo (tablet) in Part A for Cohorts 1-5
    Interventions:
    • Drug: ABI-5366
    • Drug: ABI-5366 Placebo
  • Experimental: Part A: SAD Fed Cohort 6, ABI-5366
    Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect
    Intervention: Drug: ABI-5366
  • Experimental: Part B: MAD Cohorts 1-4 ABI-5366
    Weekly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose.
    Interventions:
    • Drug: ABI-5366
    • Drug: ABI-5366 Placebo
  • Placebo Comparator: Part B: MAD Cohorts 1-4 Placebo
    Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose.
    Interventions:
    • Drug: ABI-5366
    • Drug: ABI-5366 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2024)		 146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Part A: 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Assembly Biosciences 833-509-4583 clinicaltrials@assemblybio.com
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06385327
Other Study ID Numbers  ICMJE ABI-5366-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Assembly Biosciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assembly Biosciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Gane New Zealand Clinical Research
PRS Account Assembly Biosciences
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP