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Gene-Silencing shot aims to quiet hepatitis b for good

NCT ID NCT07200193

Disease control Sponsor: nChroma Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a new therapy called CRMA-1001, which uses epigenetic gene silencing to turn off the hepatitis B virus in the body. About 66 adults with chronic hepatitis B who are already on antiviral pills will receive one or more IV infusions of the therapy. The main goal is to check safety and tolerability, while also looking at how the body processes the drug and whether it can reduce virus levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CRMA-1001 (epigenetic gene silencing therapy given by IV infusion)
What this could lead to
If successful, this could lead to a new way to control chronic hepatitis B by silencing the virus's genes, potentially reducing or eliminating the need for lifelong daily antiviral pills.
What could go wrong
This is an early phase 1/2 trial with only 66 participants, so safety and effectiveness are not yet proven. The therapy is new and may cause side effects or fail to control the virus long-term.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

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 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Male/Female, weight 45-150 kg, age 18-64, inclusive * Diagnosed with Chronic Hepatitis B * On oral antiviral therapy * ALT and AST \<= 1.5 x ULN * Total bilirubin \<= ULN Exclusion Criteria: * Significant hepatic fibrosis or cirrhosis * Current or prior liver disease other than HBV * Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection Hepatitis, Chronic

As listed by the trial registrant

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

Chronic hepaititis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospices Civils De Leon

    RECRUITING

    Lyon, 69002, France

  • King's College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • New Zealand Clinical Research

    RECRUITING

    Auckland, New Zealand

  • Queen Mary Hospital, The University of Hong Kong

    RECRUITING

    Hong Kong, 999077, Hong Kong

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