Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARO-HBV · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. Assessment of causality utilized 3 possible categories: not related, possibly related and probably related.
| Arm | Type | Description |
|---|---|---|
| ARO-HBV 35 mg | EXPERIMENTAL | Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers |
| ARO-HBV 100 mg | EXPERIMENTAL | Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers |
| ARO-HBV 200 mg | EXPERIMENTAL | Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers |
| ARO-HBV 300 mg | EXPERIMENTAL | Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers |
| ARO-HBV 400 mg | EXPERIMENTAL | Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers |
| Placebo | PLACEBO_COMPARATOR | Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers |
| ARO-HBV 25 mg, Q28D | EXPERIMENTAL | ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B |
| ARO-HBV 50 mg Q28D | EXPERIMENTAL | ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B |
| ARO-HBV 100 mg Q28D | EXPERIMENTAL | ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B |
| ARO-HBV 200 mg Q28D | EXPERIMENTAL | ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B |
| ARO-HBV 300 mg Q28D | EXPERIMENTAL | ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B |
| ARO-HBV 400 mg Q28D | EXPERIMENTAL | ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B |
| ARO-HBV 100 mg Q14D | EXPERIMENTAL | ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B |
| ARO-HBV 100 mg Q7D | EXPERIMENTAL | ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B |
| ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve | EXPERIMENTAL | ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B |
| ARO-HBV 300 mg, Q28D, HBeAg+/ NUC | EXPERIMENTAL | ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B |
| ARO-HBV 200 mg, Q7D | EXPERIMENTAL | ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B |
| ARO-HBV 300 mg, Q7D | EXPERIMENTAL | ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B |
| ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | EXPERIMENTAL | ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B |
| Name | Type | Description |
|---|---|---|
| ARO-HBV | DRUG | sc injection |
| Sterile Normal Saline (0.9% NaCl) | OTHER | sc injection |
| JNJ-56136379 | DRUG | oral tablets |
Inclusion Criteria for Parts A \& B: * Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception. * Willing to provide written informed consent and comply with study requirements Additional Inclusion Criteria for Part B:...
ARO-HBV is an investigational drug being studied for the treatment of Hepatitis B. It is a small molecule being developed by Arrowhead Pharmaceuticals. As of now, it is in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for use.
ARO-HBV is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ARWR. The drug is currently in Phase 1 clinical trials for Hepatitis B.
ARO-HBV is in Phase 1 clinical development. It is being studied in a clinical trial that has been completed. The drug is investigational and has not been approved by regulatory authorities. It is being evaluated for the treatment of Hepatitis B.
ARO-HBV has been studied in a Phase 1 clinical trial with the identifier NCT03365947. This trial was a randomized, double-blind, placebo-controlled study that included healthy volunteers and patients with Hepatitis B. The trial was conducted in Australia, Hong Kong, and New Zealand, and enrolled 114 participants.
ARO-HBV is the name of the drug being developed by Arrowhead Pharmaceuticals. No alternative names for this drug have been reported. It is a small molecule being studied for Hepatitis B, and it is currently in Phase 1 clinical development.