MRNA3771, GRNA1599 for Chronic hepatitis B

Inclusion criteria

• {"criterion_text":"- Adults ≥ 18 to < 65 years of age, at the time of signing the informed consent.\n- Chronic HBV infection, defined as positive for HBsAg for a duration of at least 6 months.\n- 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.\n- HBV DNA < 10 IU/mL (<1.0 log10 IU/mL) at Screening as determined by Central Lab.\n- HBsAg ≥ 100 IU/mL (≥2.0 log10 IU/mL) at Screening as determined by Central Lab.\n- HBeAg negative at Screening as determined by Central Lab. Exception: Part B HBeAg Positive Cohort must have HBeAg > LLOQ.\n- 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).\n- Body weight of at least 45 kg and maximally 150 kg, and BMI within the range 18 to 32 kg/m2 (inclusive).\n- Male or female participants who agree to contraceptive requirements detailed in the protocol"}

Exclusion criteria

• {"criterion_text":"- 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.\n- History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices.\n- 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).\n- Co-infection with HCV, HIV, or HDV as determined by Central Lab\n- 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).\n- 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.\n- 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.\n- Participant is pregnant or breastfeeding, or is planning a pregnancy or to breastfeed within 2 years of CRMA-1001 planned administration."}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of TEAEs from baseline to Month 6","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Incidence and severity of TEAEs after Month 6 until end of study","definition_or_measurement_approach":""}
• {"endpoint_text":"- CRMA-1001 in plasma PK parameters, including but not limited to: Cmax, Tmax, AUC, terminal clearance rate, volume of distribution","definition_or_measurement_approach":"Plasma PK parameters (examples listed: Cmax, Tmax, AUC, terminal clearance rate, volume of distribution)"}
• {"endpoint_text":"- Incidence and characterization of ADAs by Month 6","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Biomarkers evaluated as change from baseline to Month 6 and change from baseline to end of study"}
• {"endpoint_text":"- Proportion of participants able to discontinue NUC therapy by end of study","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Functional cure defined as HBsAg loss (< 0.05 IU/mL) and HBV DNA below LLOQ for ≥ 6 months after treatment and NUC discontinuation"}

France

Earliest CTIS Part Ii Submission Date

23-01-2026

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

28

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Nchroma Bio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Novotech (Australia) Pty Limited

Responsibilities

codes: [1,12,13,2,5,6]; contact email: Europe.Regulatory@novotech-cro.com

Name

Novotech Laboratory Services (Taiwan) Co. Ltd.

Responsibilities

codes: [4]; contact email: Peggy.wu@novotech-cro.com

Name

Scout Clinical

Responsibilities

codes: [15] (Patient cost reimbursement)

Third parties

• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"Novotech (Australia) Pty Limited","duties_or_roles":"codes: [1,12,13,2,5,6]; contact email: Europe.Regulatory@novotech-cro.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"codes: [15] (value: Patient cost reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"France","full_name":"Cerba","duties_or_roles":"codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: [7]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Taiwan","full_name":"Novotech Laboratory Services (Taiwan) Co. Ltd.","duties_or_roles":"codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}