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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06385327




Registration number
NCT06385327
Ethics application status
Date submitted
18/04/2024
Date registered
26/04/2024

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
ABI-5366-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Genital Herpes Simplex Type 2 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-5366
Treatment: Drugs - ABI-5366 Placebo

Experimental: Part A: SAD Cohorts 1-5, ABI-5366 - Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5

Placebo comparator: Part A: SAD Cohorts 1-5, Placebo - Single dose of matching placebo (tablet) in Part A for Cohorts 1-5

Experimental: Part A: SAD Fed Cohort 6, ABI-5366 - Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect

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.

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.


Treatment: Drugs: ABI-5366
Once daily tablet dosing (SAD) or Weekly tablet dosing over 29 days (MAD)

Treatment: Drugs: ABI-5366 Placebo
Once daily tablet dosing (SAD) or Weekly tablet dosing over 29 days (MAD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Timepoint [1] 0 0
Up to 70 days after last dose
Primary outcome [2] 0 0
Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) of ABI-5366
Timepoint [3] 0 0
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.
Primary outcome [4] 0 0
Time to Cmax (Tmax) of ABI-5366
Timepoint [4] 0 0
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.
Primary outcome [5] 0 0
Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366
Timepoint [5] 0 0
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.
Primary outcome [6] 0 0
Apparent Systemic Clearance (CL/F) of ABI-5366
Timepoint [6] 0 0
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.
Primary outcome [7] 0 0
Apparent Volume of Distribution (Vz/F) of ABI-5366
Timepoint [7] 0 0
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.
Primary outcome [8] 0 0
Dose normalized AUCs and Cmax of ABI-5366
Timepoint [8] 0 0
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.
Secondary outcome [1] 0 0
SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments
Timepoint [1] 0 0
SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing.
Secondary outcome [2] 0 0
MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses
Timepoint [2] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [3] 0 0
MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments
Timepoint [3] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [4] 0 0
MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments
Timepoint [4] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [6] 0 0
MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments
Timepoint [6] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [7] 0 0
MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments
Timepoint [7] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [9] 0 0
MAD Cohorts: Difference in lesion rate during the swabbing period across treatments
Timepoint [9] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [10] 0 0
MAD Cohorts: Difference in lesion duration during the swabbing period across treatments
Timepoint [10] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.
Secondary outcome [11] 0 0
MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments
Timepoint [11] 0 0
MAD Cohorts: At pre-specified time points from Days 8 to 36.

Eligibility
Key inclusion criteria
Part A:

* 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:

* 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:
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Assembly Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward Gane
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Assembly Biosciences
Address 0 0
Country 0 0
Phone 0 0
833-509-4583
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06385327