Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the trial.

2. Male or female participant aged 18 to 65 years, inclusive.

3. Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at the time of the screening visit.

4. Documented evidence of HDV infection in medical history, i.e., HDV antibodies (HDVAb) and/or HDV RNA positive test results within at least 6 months prior toscreening.

5. Documented evidence of HBV infection in medical history, i.e., HBsAg and/or HBV DNApositive test results within at least 6 months prior to screening.

6. Documented absence of liver cirrhosis, defined as an LSM ≥ 10 kPa measured onFibroScan® elastography at screening.

Exclusion Criteria:

1. Laboratory results at screening as follows, or any clinically significant laboratoryparameter outliers that may interfere with the evaluation of efficacy and/or safetyin the trial, at the discretion of the Investigator:

• α-fetoprotein (AFP) > 50 µg/L.

• Albumin concentration < 3.0 g/dL.

• International normalized ratio (INR) > 1.5.

• Platelet count < 90 × 109/L.

• Direct bilirubin > 2 × ULN, Gilbert syndrome excluded.

• Creatinine concentration > 1.5 × ULN.

• Creatinine clearance < 60 mL/min, according to the Cockcroft-Gaultequation.

2. Positive result at screening for hepatitis C virus (HCV) and/or humanimmunodeficiency virus (HIV) and/or prior diagnosis of syphilis, acute hepatitis Aand/or acute hepatitis E.

3. Prior diagnosis of other liver diseases of non-HBV or non-HDV aetiology, includingautoimmune liver disease (e.g., autoimmune hepatitis, primary biliary cholangitis orprimary sclerosing cholangitis), inherited metabolic liver disease (e.g.,haemochromatosis, Wilson's disease, familial intrahepatic cholestasis), drug-inducedliver disease and/or non alcoholic steatohepatitis (NASH) assessed as moderate orabove, at the discretion of the Investigator.

4. Prior or current diagnosis of liver cirrhosis.

5. History of or active hepatic decompensation, e.g., ascites, variceal bleeding orhepatic encephalopathy, at the discretion of the Investigator.

6. History of organ transplantation, previous or concurrent HCC or imaging findingsuggesting malignant liver lesions, at the discretion of the Investigator.

7. Signs of liver malignancy in abdominal ultrasound at screening.