Chronic Hepaititis BPhase 1/2NCT07200193
A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
A Phase 1/2 study testing CRMA-1001 in people with Chronic Hepaititis B, run by nChroma Bio at 4 sites in 4 countries.
Trial summary
This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Hepaititis B
- What is being tested?
- CRMA-1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 22 Dec 2025to 31 Dec 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than HBV
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
France1 site, 1 recruiting
- Recruiting
Hospices Civils De Leon
Lyon, 69002
Fabien Zoulim
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong, 999077
Man Fung Yuen
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Auckland
Edward Gane
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Kaushik Agarwal
About this study
Official title: A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B
This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.
- Conditions
- Chronic Hepaititis B
- Being tested
- CRMA-1001
- Keywords
- CHB, Chronic hepatitis B, Chronic HBV, Chronic Hep B, Chronic hepatitis, HBV
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRMA-1001Genetic
Epigenetic gene silencing therapy delivered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| CRMA-1001 Part A, SAD | Experimental | Single ascending dose arm Receives: Genetic: CRMA-1001 |
| CRMA-1001 Part A, MAD | Experimental | Multiple ascending dose arm Receives: Genetic: CRMA-1001 |
| CRMA-1001 Part B | Experimental | Dose expansion Receives: Genetic: CRMA-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single and multiple doses of CRMA-1001
Incidence and severity of treatment-emergent adverse events
Measured: 6 months
Secondary outcomes (18)
Long-term safety of single and multiple doses of CRMA-1001
Incidence and severity of treatment emergent adverse events
Measured: 60 Months
Pharmacokinetics of CRMA-1001 components (Cmax)
Maximum concentration (Cmax) in plasma
Measured: 6 Months
Pharmacokinetics of CRMA-1001 components (Tmax)
Time of maximum concentration (Tmax) in plasma
Measured: 6 Months
Pharmacokinetics of CRMA-1001 components (terminal clearance rate)
Clearance rate in terminal clearance phase (CL) in plasma
Measured: 6 Months
Pharmacokinetics of CRMA-1001 components (Vd)
Volume of distribution (Vd) in plasma
Measured: 6 Months
To evaluate the immunogenicity of CRMA-1001
Incidence and characterization of anti-drug antibodies
Measured: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)
Change from baseline in HBsAg
Measured: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)
Change from baseline in anti-HBs antibody titier
Measured: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)
Change from baseline in HBV DNA
Measured: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)
Change from baseline in HBeAg
Measured: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)
Change from baseline in anti-HBe antibody titer
Measured: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)
Change from baseline in HBsAg
Measured: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)
Change from baseline in anti-HBs antibody titer
Measured: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)
Change from baseline in HBV DNA
Measured: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)
Change from baseline in HBeAg
Measured: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)
Change from baseline in anti-HBe antibody titer
Measured: 60 Months
To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001
Proportion of participants able to discontinue antiviral therapy
Measured: 60 Months
To evaluate the effect of CRMA-1001 on the incidence of functional cure
Incidence of functional cure
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start22 Dec 2025
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepaititis BStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nChroma Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200193
- Sponsor's protocol ID
- CRMA-1001-101
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07200193
- Acronym / sponsor ID
- CRMA-1001-101
- Conditions
- Chronic Hepaititis B
- Keywords
- CHB, Chronic hepatitis B, Chronic HBV, Chronic Hep B, Chronic hepatitis, HBV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- nChroma BioIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 30 Sep 2025 (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 is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRMA-1001 Part A, SAD | Experimental | Genetic: CRMA-1001Single ascending dose arm |
| CRMA-1001 Part A, MAD | Experimental | Genetic: CRMA-1001Multiple ascending dose arm |
| CRMA-1001 Part B | Experimental | Genetic: CRMA-1001Dose expansion |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than HBV
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| CRMA-1001Epigenetic gene silencing therapy delivered by intravenous (IV) infusion | Genetic | CRMA-1001 Part A, MAD, CRMA-1001 Part A, SAD, CRMA-1001 Part B |
Primary outcome
Safety and tolerability of single and multiple doses of CRMA-1001
Time frame: 6 months
Incidence and severity of treatment-emergent adverse events
18 secondary outcomes
Long-term safety of single and multiple doses of CRMA-1001
Time frame: 60 Months
Pharmacokinetics of CRMA-1001 components (Cmax)
Time frame: 6 Months
Pharmacokinetics of CRMA-1001 components (Tmax)
Time frame: 6 Months
Pharmacokinetics of CRMA-1001 components (terminal clearance rate)
Time frame: 6 Months
Pharmacokinetics of CRMA-1001 components (Vd)
Time frame: 6 Months
To evaluate the immunogenicity of CRMA-1001
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)
Time frame: 6 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)
Time frame: 60 Months
To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001
Time frame: 60 Months
To evaluate the effect of CRMA-1001 on the incidence of functional cure
Time frame: 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRMA-1001 in people with Chronic Hepaititis B, run by nChroma Bio at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Hong Kong, New Zealand, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nChroma Bio ((617) 915 6203, CRMA-1001-101-Study@nchromabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of single and multiple doses of CRMA-1001 (time frame: 6 months). 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 15 Jun 2026.