Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INO-1800 · 1 trial · 1 indication
Composite outcome measure consisting of multiple measures, including: 1. Local pain immediately after Study Treatment/EP and at select times using a visual analog scale (VAS) from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" 2. Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP 3. Frequency and severity of laboratory abnormalities 4. Frequency and severity of all adverse events 5. Changes in vital signs
| Arm | Type | Description |
|---|---|---|
| Group A: low dose, standard regimen | EXPERIMENTAL | 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. |
| Group A: mid dose, standard regimen | EXPERIMENTAL | 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. |
| Group A: high dose, standard regimen | EXPERIMENTAL | 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. |
| Group B: mid dose, standard regimen | EXPERIMENTAL | 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. |
| Group B: high dose, standard regimen | EXPERIMENTAL | 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. |
| Active Control: nucleos(t)ide analogue treatment | ACTIVE_COMPARATOR | Participants continued treatment with nucleos(t)ide analogue treatment. |
| Name | Type | Description |
|---|---|---|
| INO-1800 | BIOLOGICAL | INO-1800 delivered by EP |
| INO-9112 | BIOLOGICAL | INO-9112 delivered by EP |
| Nucleos(t)ide Analogue Treatment | DRUG | Continued treatment with nucleos(t)ide analogue |
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 plate...
INO-1800 is an investigational monoclonal antibody being studied for the treatment of Hepatitis B. It is currently in Phase 1 clinical development. The drug is being evaluated in patients with chronic Hepatitis B, as part of a study that also tested it with or without an additional investigational agent.
INO-1800 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. The company is conducting clinical research on this investigational drug for Hepatitis B.
INO-1800 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of INO-1800 has been completed, involving 90 participants with chronic Hepatitis B.
INO-1800 has been studied in one clinical trial, identified as NCT02431312. This was a Phase 1 study titled 'Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects.' The trial has been completed and enrolled 90 participants.
No, INO-1800 is not the same as INO-9112. INO-1800 is the investigational drug being studied for Hepatitis B, while INO-9112 is a separate investigational agent that was tested in combination with INO-1800 in a clinical trial. They are distinct drug candidates.