Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03365947 | Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV) | PHASE1 | COMPLETED | 114 | — | — | Mar 27, 2018 | Apr 23, 2020 | Oct 22, 2025 | 7 | Australia, Hong Kong +1 |
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:...