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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
Date last updated
25/09/2024

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 or monthly 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 or monthly 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 or monthly tablet dosing over 29 days (MAD)

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

Outcomes
Primary outcome [1] 0 0
Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366
Timepoint [1] 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 [2] 0 0
Maximum Observed Plasma Concentration (Cmax) 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
Time to Cmax (Tmax) 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
Apparent Terminal Elimination Half Life (t 1/2) 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 Systemic Clearance (CL/F) 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 Volume of Distribution (Vz/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
Dose normalized AUCs and Cmax 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
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Timepoint [8] 0 0
Up to 98 days after last dose
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 administering 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
1/08/2025
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Sutherland Shire Clinical Research - Miranda
Recruitment hospital [2] 0 0
Momentum Clinical Research - Sydney
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Sydney
Recruitment hospital [4] 0 0
Wollongong Clinical Research - Wollongong
Recruitment hospital [5] 0 0
Gold Coast Sexual Health Centre - Southport
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2100 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06385327
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06385327