Recurrent Genital Herpes Simplex Type 2Phase 1NCT06385327
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
A Phase 1 study testing ABI-5366 in people with Recurrent Genital Herpes Simplex Type 2, run by Assembly Biosciences at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Genital Herpes Simplex Type 2
- What is being tested?
- ABI-5366
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 30 May 2024to 3 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
New Zealand8 sites
New Zealand Clinical Research
Auckland, 1010
New Zealand Clinical Research Christchurch
Christchurch, 8011
Pacific Clinical Research Network - Hamilton
Hamilton, 3200
Pacific Clinical Research Network - Tasman
Nelson, 7011
Momentum Palmerston North
Palmerston North, 4414
Pacific Clinical Research Network - Rotorua
Rotorua, 3010
Pacific Clinical Research Network - Wellington
Upper Hutt, 5018
Momentum Kapiti
Waikanae, 5036
Australia7 sites
East Sydney Doctors
Darlinghurst, New South Wales, 2010
Momentum Sunshine
Melbourne, Victoria, 3021
Canopy Clinical Sutherland
Miranda, New South Wales, 2228
Royal Melbourne Hospital
Parkville, Victoria, 3050
Momentum Clinical Research
Sydney, New South Wales, 2010
Canopy Beaches Clinical Research
Sydney, New South Wales, 2100
Canopy Clinical Wollongong
Wollongong, New South Wales, 2500
About this study
Official 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
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.
- Conditions
- Recurrent Genital Herpes Simplex Type 2
- Being tested
- ABI-5366, ABI-5366 Placebo
- Keywords
- ABI-5366, PK, Healthy Participants, HSV-2, Recurrent Genital Herpes
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-5366Drug
Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)
ABI-5366 PlaceboDrug
Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-5366 | Experimental | Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5 Receives: Drug: ABI-5366; Drug: ABI-5366 Placebo |
| Part A: SAD Cohorts 1-5, Placebo | Placebo comparator | Single dose of matching placebo (tablet) in Part A for Cohorts 1-5 Receives: Drug: ABI-5366; Drug: ABI-5366 Placebo |
| Part A: SAD Fed Cohort 6, ABI-5366 | Experimental | Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect Receives: Drug: ABI-5366 |
| Part B: MAD Cohorts 1-4 ABI-5366 | Experimental | Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose. Receives: Drug: ABI-5366; Drug: ABI-5366 Placebo |
| Part B: MAD Cohorts 1-4 Placebo | Placebo comparator | Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose. Receives: Drug: ABI-5366; Drug: ABI-5366 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Measured: Up to 98 days after last dose
Secondary outcomes (11)
SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in lesion rate during the swabbing period across treatments
Measured: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in lesion duration during the swabbing period across treatments
Measured: 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
Measured: MAD Cohorts: At pre-specified time points from Days 8 to 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start30 May 2024
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Genital Herpes Simplex Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385327
- Sponsor's protocol ID
- ABI-5366-101
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06385327
- Acronym / sponsor ID
- ABI-5366-101
- Conditions
- Recurrent Genital Herpes Simplex Type 2
- Keywords
- ABI-5366, PK, Healthy Participants, HSV-2, Recurrent Genital Herpes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-5366 | Experimental | Drug: ABI-5366, Drug: ABI-5366 PlaceboSingle dose of ABI-5366 (tablet) in Part A for Cohorts 1-5 |
| Part A: SAD Cohorts 1-5, Placebo | Placebo comparator | Drug: ABI-5366, Drug: ABI-5366 PlaceboSingle dose of matching placebo (tablet) in Part A for Cohorts 1-5 |
| Part A: SAD Fed Cohort 6, ABI-5366 | Experimental | Drug: ABI-5366Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect |
| Part B: MAD Cohorts 1-4 ABI-5366 | Experimental | Drug: ABI-5366, Drug: ABI-5366 PlaceboWeekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
| Part B: MAD Cohorts 1-4 Placebo | Placebo comparator | Drug: ABI-5366, Drug: ABI-5366 PlaceboWeekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-5366Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) | Drug | Part A: SAD Cohorts 1-5, ABI-5366, Part A: SAD Cohorts 1-5, Placebo, Part A: SAD Fed Cohort 6, ABI-5366, Part B: MAD Cohorts 1-4 ABI-5366, Part B: MAD Cohorts 1-4 Placebo |
| ABI-5366 PlaceboOnce daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) | Drug | Part A: SAD Cohorts 1-5, ABI-5366, Part A: SAD Cohorts 1-5, Placebo, Part B: MAD Cohorts 1-4 ABI-5366, Part B: MAD Cohorts 1-4 Placebo |
Primary outcome
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.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Time frame: Up to 98 days after last dose
11 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-5366 in people with Recurrent Genital Herpes Simplex Type 2, run by Assembly Biosciences at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.