Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
Status and phase
Completed
Phase 1
Conditions
Hepatitis B
Treatments
Drug: Nucleos(t)ide Analogue Treatment
Biological: INO-9112
Biological: INO-1800
Details and patient eligibility
About
This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.
Enrollment
90 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Chronic Hepatitis B virus infection
- Negative for Hepatitis A IgM, C, D and HIV
- Liver biopsy, Fibroscan® or equivalent elastography-based test obtained within the past 6 months demonstrating liver disease without evidence of bridging fibrosis or cirrhosis supported by platelet count greater than the central laboratory LLN at screening
- Positive for Hepatitis B surface antigen (≥250 IU/mL at screening)
- Nucleos(t)ide treatment for at least 1 year with ongoing nucleos(t)ide analogue treatment at randomization
- HBV DNA <90 IU/mL for ≥6 months prior to randomization
- Screening laboratory values within normal range
- ALT ≤1.5x upper limit of normal (ULN) from 2 measurements separated by at least 14 days during the 6 months prior to randomization and ALT at screening ≤1.5x ULN
- AST, TBili, DBili, GGT, Alk Phos and albumin within normal range or judged to be not clinically significant by PI and medical monitor at screening
- For men and women who are not postmenopausal [i.e. ≥ 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone (FSH), if not on hormone replacement] or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females) agreement to remain abstinent or use 1 highly effective or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and at least through week 12 after last dose
Exclusion criteria
- Pregnant or breastfeeding females
- Positive serum pregnancy test at screening or positive urine pregnancy test at randomization
- Use of topical corticosteroids at or near the intended administration site
- Autoimmune disorders, transplant recipients, other immunosuppression including any concurrent condition requiring the use of immunosuppressive/immunomodulating agents (eye drop-containing and infrequent inhaled corticosteroids are permissible)
- Need for systemic antiviral treatment (other than for chronic hepatitis B infection)
- Documented history or other evidence of decompensated liver disease (e.g., ascites, bleeding from esophageal varices, Child-Pugh clinical classification B or C)
- History of liver cirrhosis demonstrated by biopsy, Fibroscan® or equivalent elastography-based test
- History of other evidence of a medical condition associated with chronic liver disease [e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis (NASH), toxin exposure, thalassemia, etc.]
- Documented history or other evidence of metabolic liver disease within 1yr of randomization
- Abnormal renal function including serum creatinine >ULN or calculated creatinine clearance <70 mL/min (using the Cockcroft Gault formula)
- History of or suspicion of HCC
- Screening alpha fetoprotein ≥13 ng/mL
- Prior history or current malignancy other than adequately treated BCC, unless history of BCC is near intended administration site
- History of significant medical conditions [e.g., cardiac (including ventricular or supraventricular arrhythmias), renal disease, pulmonary, gastrointestinal, neurological]
- Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization
- Administration of any blood product within 3 mon of randomization
- History of seizures (unless seizure free for 5yrs)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
None (Open label)
90 participants in 6 patient groups
Group A: low dose, standard regimen
Experimental group
Description:
Participants received 3 or 4 doses of 0.3 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
Treatment:
Biological: INO-1800
Drug: Nucleos(t)ide Analogue Treatment
Group A: mid dose, standard regimen
Experimental group
Description:
Participants received 3 or 4 doses of 2 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
Treatment:
Biological: INO-1800
Drug: Nucleos(t)ide Analogue Treatment
Group A: high dose, standard regimen
Experimental group
Description:
Participants received 3 or 4 doses of 9 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
Treatment:
Biological: INO-1800
Drug: Nucleos(t)ide Analogue Treatment
Group B: mid dose, standard regimen
Experimental group
Description:
Participants received 3 or 4 doses of 2 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
Treatment:
Biological: INO-1800
Biological: INO-9112
Drug: Nucleos(t)ide Analogue Treatment
Group B: high dose, standard regimen
Experimental group
Description:
Participants received 3 or 4 doses of 9 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
Treatment:
Biological: INO-1800
Biological: INO-9112
Drug: Nucleos(t)ide Analogue Treatment
Active Control: nucleos(t)ide analogue treatment
Active Comparator group
Description:
Participants continued treatment with nucleos(t)ide analogue treatment.
Treatment:
Drug: Nucleos(t)ide Analogue Treatment
Trial contacts and locations
22
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Data sourced from clinicaltrials.gov
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