Recurrent Genital Herpes Simplex Type 2Phase 1NCT06698575
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
A Phase 1 study testing ABI-1179 in people with Recurrent Genital Herpes Simplex Type 2, run by Assembly Biosciences at 18 sites in 3 countries.
Trial summary
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 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-1179
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 8 Dec 2024to 19 Jan 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 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, whatever is longer.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
New Zealand8 sites
New Zealand Clinical Research
Auckland, New Zealand, 1010
New Zealand Clinical Research
Christchurch, New Zealand, 8011
Pacific Clinical Research Network
Hamilton, New, 3200
Pacific Clinical Research Network
Nelson, New Zealand, 7011
Momentum Palmerston North
Palmerston North, New Zealand, 4414
Pacific Clinical Research Network
Rotorua, New Zealand, 3010
Pacific Clinical Research Network
Upper Hutt, New Zealand, 5018
Momentum Kapiti
Waikanae, New Zealand, 5036
Australia6 sites
East Sydney Doctors
Darlinghurst, Australia, 2010
Momentum Sunshine
Melbourne, Au, 3021
Royal Melbourne Hospital
Parkville, Australia, 3050
Taylor Square Private Clinic
Surry Hills, Australia, 2010
Momentum Clinical Research
Sydney, Australia, 2010
Canopy Clinical Wollongong
Wollongong, Australia, 2500
United States4 sites
Alliance for Multispecialty Research
Kansas City, Missouri, 64114
Rochester Clinical Research
Rochester, New York, 14609
Seattle Clinical Research Center
Seattle, Washington, 98104
University of Washington Virology Research Clinic
Seattle, Washington, 98104
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-1179 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-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 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-1179, ABI-1179 Placebo
- Keywords
- ABI-1179, 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-1179Drug
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 PlaceboDrug
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-1179 | Experimental | Single dose of ABI-1179 (tablet) in Part A for cohorts 1-5 Receives: Drug: ABI-1179; Drug: ABI-1179 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-1179; Drug: ABI-1179 Placebo |
| Part A: (SAD) Fed Cohort 6 or 7, ABI-1179 | Experimental | Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect Receives: Drug: ABI-1179; Drug: ABI-1179 Placebo |
| Part B: MAD Cohorts 1-4, ABI-1179 | Experimental | Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose. Receives: Drug: ABI-1179; Drug: ABI-1179 Placebo |
| Part B: MAD Cohorts 1-4 Placebo | Placebo comparator | Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4. Receives: Drug: ABI-1179; Drug: ABI-1179 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-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Time to Cmax (Tmax) of ABI-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 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) ABI-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 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 AE's and abnormal laboratory results.
Measured: Up to 56 days after last dose.
Secondary outcomes (12)
SAD Cohorts: Comparison of Plasma AUC between fasted and fed treatments
Measured: MAD Cohorts: At pre-specified time points from Days 8 to 36.
SAD Cohorts: Comparison of plasma Cmax between fasted and fed treatments
Measured: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing.
MAD Cohort: If applicable comparison of plasma AUC and Cmax with and without loading doses
Measured: MAD Cohorts At pre-specified timepoints 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: 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>4log10 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 the 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 the 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 the 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 posted21 Nov 2024
- Study start8 Dec 2024
- Primary completion19 Jan 2026
- Study completion19 Jan 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
- 103 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
- NCT06698575
- Sponsor's protocol ID
- ABI-1179-101
- Status last verified
- Aug 2025
- First submitted
- 8 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 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-1179 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes
- ClinicalTrials.gov ID
- NCT06698575
- Acronym / sponsor ID
- ABI-1179-101
- Conditions
- Recurrent Genital Herpes Simplex Type 2
- Keywords
- ABI-1179, PK, Healthy Participants, HSV-2, Recurrent Genital Herpes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2024 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 21 Nov 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-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 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-1179 | Experimental | Drug: ABI-1179, Drug: ABI-1179 PlaceboSingle dose of ABI-1179 (tablet) in Part A for cohorts 1-5 |
| Part A:SAD Cohorts 1-5, Placebo | Placebo comparator | Drug: ABI-1179, Drug: ABI-1179 PlaceboSingle dose of matching placebo (tablet) in Part A for Cohorts 1-5 |
| Part A: (SAD) Fed Cohort 6 or 7, ABI-1179 | Experimental | Drug: ABI-1179, Drug: ABI-1179 PlaceboSingle dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect |
| Part B: MAD Cohorts 1-4, ABI-1179 | Experimental | Drug: ABI-1179, Drug: ABI-1179 PlaceboWeekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose. |
| Part B: MAD Cohorts 1-4 Placebo | Placebo comparator | Drug: ABI-1179, Drug: ABI-1179 PlaceboWeekly dose of matching placebo (tablet) in Part B for Cohorts 1-4. |
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-1179Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD) | Drug | Part A: (SAD) Fed Cohort 6 or 7, ABI-1179, Part A: SAD Cohorts 1-5, ABI-1179, Part A:SAD Cohorts 1-5, Placebo, Part B: MAD Cohorts 1-4 Placebo, Part B: MAD Cohorts 1-4, ABI-1179 |
| ABI-1179 PlaceboOnce daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD) | Drug | Part A: (SAD) Fed Cohort 6 or 7, ABI-1179, Part A: SAD Cohorts 1-5, ABI-1179, Part A:SAD Cohorts 1-5, Placebo, Part B: MAD Cohorts 1-4 Placebo, Part B: MAD Cohorts 1-4, ABI-1179 |
Primary outcome
Area Under the Plasma Concentration Time Curve, (AUC) of ABI-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Time to Cmax (Tmax) of ABI-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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) ABI-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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-1179
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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 AE's and abnormal laboratory results.
Time frame: Up to 56 days after last dose.
12 secondary outcomes
SAD Cohorts: Comparison of Plasma AUC between fasted and fed treatments
Time frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
SAD Cohorts: Comparison of plasma Cmax between fasted and fed treatments
Time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing.
MAD Cohort: If applicable comparison of plasma AUC and Cmax with and without loading doses
Time frame: MAD Cohorts At pre-specified timepoints 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: 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>4log10 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 the 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 the 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 the 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 23 Mar 2026.
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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.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-1179 in people with Recurrent Genital Herpes Simplex Type 2, run by Assembly Biosciences at 18 sites in 3 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 23 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 18 sites in New Zealand, Australia, United States. 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-1179 (time frame: SAD Cohorts: before and at pre-specified timepoints up to 144 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 23 Mar 2026.