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New herpes drug enters early human testing

NCT ID NCT06385327

Disease control Sponsor: Assembly Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called ABI-5366 in 115 people to see if it is safe and how the body processes it. Part A involved healthy volunteers receiving a single dose, while Part B included people with recurrent genital herpes who received multiple doses. The goal is to gather safety and dosing information for future studies, not to cure the infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

115 people

The number who actually took part.

Started

May 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

genital herpes genital herpes simplex type 2 infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent genital herpes simplex type 2

Contacts and locations

Locations

  • Canopy Beaches Clinical Research

    Sydney, New South Wales, 2100, Australia

  • Canopy Clinical Sutherland

    Miranda, New South Wales, 2228, Australia

  • Canopy Clinical Wollongong

    Wollongong, New South Wales, 2500, Australia

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010, Australia

  • Momentum Clinical Research

    Sydney, New South Wales, 2010, Australia

  • Momentum Kapiti

    Waikanae, 5036, New Zealand

  • Momentum Palmerston North

    Palmerston North, 4414, New Zealand

  • Momentum Sunshine

    Melbourne, Victoria, 3021, Australia

  • New Zealand Clinical Research

    Auckland, 1010, New Zealand

  • New Zealand Clinical Research Christchurch

    Christchurch, 8011, New Zealand

  • Pacific Clinical Research Network - Hamilton

    Hamilton, 3200, New Zealand

  • Pacific Clinical Research Network - Rotorua

    Rotorua, 3010, New Zealand

  • Pacific Clinical Research Network - Tasman

    Nelson, 7011, New Zealand

  • Pacific Clinical Research Network - Wellington

    Upper Hutt, 5018, New Zealand

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.