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
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