A Study of the Safety, Tolerability, PK, PD, and Efficacy of CRMA-1001 in Chronic Hepatitis B

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nchroma Bio Inc.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

22 May 2026 → ongoing

Decision date (initial)

2026-02-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

nChroma Bio, Inc.

External identifiers

EU CT number

2025-523619-12-00

ClinicalTrials.gov

NCT07200193

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacodynamic, Efficacy, Others

To assess the safety and tolerability of single and multiple doses of CRMA-1001

Secondary objectives 6

1. To assess long-term safety of single and multiple doses of CRMA-1001
2. To evaluate the PK parameters (effector mRNA, gRNA and ionizable lipid) of single and multiple doses of CRMA-1001
3. To evaluate the immunogenicity of CRMA-1001
4. To evaluate the effect of CRMA-1001 on circulating blood HBV biomarkers
5. To evaluate the rate of NUC therapy discontinuation after treatment with CRMA-1001
6. To evaluate the effect of CRMA-1001 on the incidence of functional cure

Conditions and MedDRA coding

Chronic Hepatitis B

Regulatory references

Scientific advice from competent authorities

Medicines And Healthcare Products Regulatory Agency, National Agency For The Safety Of Medicine And Health Products

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Adults ≥ 18 to < 65 years of age, at the time of signing the informed consent.
2. Chronic HBV infection, defined as positive for HBsAg for a duration of at least 6 months.
3. On stable NUC treatment, defined as receiving the same NUC in the 6 months prior to enrollment, and expected to remain on the same NUC for the duration of study participation or until protocol-specified NUC discontinuation criteria are met. Tenofovir (as TAF, TDF, or TDF maleate) and ETV are permitted. Other NUC treatment will require consultation with the medical monitor to determine eligibility.
4. HBV DNA < 10 IU/mL (<1.0 log10 IU/mL) at Screening as determined by Central Lab.
5. HBsAg ≥ 100 IU/mL (≥2.0 log10 IU/mL) at Screening as determined by Central Lab.
6. HBeAg negative at Screening as determined by Central Lab. Exception: Part B HBeAg Positive Cohort must have HBeAg > LLOQ.
7. Participant has the following laboratory parameters at screening by central laboratory: a. ALT and AST ≤ 1.5 × ULN, confirmed by local or central lab within 7 days of dosing if assessed prior to Day -28. b. Total bilirubin ≤ ULN (Note: isolated bilirubin ≤ 1.5 × ULN is acceptable for patients with documented Gilbert’s syndrome). c. PT, INR, and aPTT ≤ ULN (Note: PT and/or aPTT > ULN is acceptable if considered not clinically significant by investigator, INR and other parameters of liver function are within normal limits, and there are no current or historical concerns. Retesting is permitted). d. Hemoglobin ≥10 g/dL. e. Platelets ≥ the LLN. f. WBC ≤ ULN and ANC ≥1000/µl. g. eGFR ≥ 60 mL/min/1.73m2 (Inker, 2021).
8. Body weight of at least 45 kg and maximally 150 kg, and BMI within the range 18 to 32 kg/m2 (inclusive).
9. Male or female participants who agree to contraceptive requirements detailed in the protocol

Exclusion criteria 8

1. Significant fibrosis or cirrhosis as defined by any of the following: a.      FibroScan result > 8.5 kPa during screening. A FibroScan obtained within the prior 12 months is acceptable if a report is available for investigator review. b.     Prior liver biopsy with Metavir F3 fibrosis or F4 cirrhosis.
2. History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices.
3. History or presence of a medical condition associated with liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, non-alcoholic steatohepatitis) or other known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
4. Co-infection with HCV, HIV, or HDV as determined by Central Lab
5. AFP >100 ng/mL. a. Note: Participants with AFP >ULN but ≤100 ng/mL may be eligible if HCC can be ruled out based on a sensitive imaging study (e.g., contrast enhanced ultrasound, CT, or MRI during screening).
6. Receiving or expected to need any other systemic antiviral therapy at any time during participation in the study, with the exception of current NUC treatment and oral/topical therapy for HSV.
7. ECG during screening showing clinically relevant abnormalities (including arrhythmias or marked QT abnormalities [QTcF < 300 msec or > 450 msec]), or other cardiac abnormalities that are considered clinically significant by the investigator. Known risk factors for Torsade de Pointes (e.g., hypokalemia, heart failure), or a personal or family history of congenital long QT syndrome.
8. Participant is pregnant or breastfeeding, or is planning a pregnancy or to breastfeed within 2 years of CRMA-1001 planned administration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence and severity of TEAEs from baseline to Month 6

Secondary endpoints 6

1. Incidence and severity of TEAEs after Month 6 until end of study
2. CRMA-1001 in plasma PK parameters, including but not limited to: Cmax, Tmax, AUC, terminal clearance rate, volume of distribution
3. Incidence and characterization of ADAs by Month 6
4. Change in HBsAg; Change in anti-HBs antibody titer; Change in HBV DNA; Change in HBeAg in HBeAg-positive participants; Change in anti-HBe antibody titer in HBeAg positive participants. (All biomarkers will be evaluated as change from baseline to Month 6 and change from baseline to end of study)
5. Proportion of participants able to discontinue NUC therapy by end of study
6. Incidence of functional cure (HBsAg loss [less than 0.05 IU/mL] and HBV DNA below the LLOQ ≥ 6 months after CRMA-1001 treatment and discontinuation of NUC therapy) by end of study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nchroma Bio Inc.

Sponsor organisation

Nchroma Bio Inc.

Address

201 Brookline Avenue Suite 1101

City

Boston

Postcode

02215-4153

Country

United States

Scientific contact point

Organisation

Nchroma Bio Inc.

Contact name

Tracy McGregor

Public contact point

Organisation

Nchroma Bio Inc.

Contact name

Tracy McGregor

Third parties 8

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications