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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-HBV | Drug | sc injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | 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. | NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose | |
| Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
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Inclusion Criteria for Parts A & B:
Additional Inclusion Criteria for Part B:
Exclusion Criteria:
NOTE: additional inclusion/exclusion criteria may apply, per protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 5 | Camperdown | New South Wales | 2050 | Australia | ||
| Research Site 4 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35870702 | Result | Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. J Hepatol. 2022 Nov;77(5):1287-1298. doi: 10.1016/j.jhep.2022.07.010. Epub 2022 Jul 20. | |
| 35695169 |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARO-HBV 35 mg | Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers |
| FG001 | ARO-HBV 100 mg | Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers |
| FG002 | ARO-HBV 200 mg | Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers |
| FG003 | ARO-HBV 300 mg | Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers |
| FG004 | ARO-HBV 400 mg | Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers |
| FG005 | Placebo | Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers |
| FG006 | ARO-HBV 25 mg, Q28D | ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B |
| FG007 | ARO-HBV 50 mg Q28D | ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B |
| FG008 | ARO-HBV 100 mg Q28D | ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B |
| FG009 | ARO-HBV 200 mg Q28D | ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B |
| FG010 | ARO-HBV 300 mg Q28D | ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B |
| FG011 | ARO-HBV 400 mg Q28D | ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B |
| FG012 | ARO-HBV 100 mg Q14D | ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B |
| FG013 | ARO-HBV 100 mg Q7D | ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B |
| FG014 | ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B |
| FG015 | ARO-HBV 300 mg, Q28D, HBeAg+/NUC | ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B |
| FG016 | ARO-HBV 200 mg, Q7D | ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B |
| FG017 | ARO-HBV 300 mg, Q7D | ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B |
| FG018 | ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARO-HBV 35 mg | Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers |
| BG001 | ARO-HBV 100 mg | Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | 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. | Safety Population: all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days) |
|
From the screening period (Day -60) and up to the end of the follow-up of the study (Day 398)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARO-HBV 35 mg | Single dose of ARO-HBV 35 mg sc injection in normal healthy volunteers |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperparathyroidism | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Arrowhead Pharmaceuticals, Inc. | 626-304-3400 | info@arrowheadpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2020 | Mar 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2020 | May 6, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C000716080 | JNJ-56136379 |
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|
| 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 |
|
| Sterile Normal Saline (0.9% NaCl) | Other | sc injection |
|
| JNJ-56136379 | Drug | oral tablets |
|
| Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose |
| Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
| Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t) | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
| Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
| Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose |
| Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
| Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
| Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | Part B (multiple-ascending dose [MAD] phase) only: up to 113 days |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Research Site 3 | Melbourne | Victoria | 3065 | Australia |
| Research Site 6 | Nedlands | Western Australia | 6009 | Australia |
| Research Site 7 | Hong Kong | Hong Kong |
| Research Site 1 | Grafton | Auckland | 1010 | New Zealand |
| Research Site 2 | Papatoetoe | Auckland | 2025 | New Zealand |
| Derived |
| Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856. |
| BG002 | ARO-HBV 200 mg | Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers |
| BG003 | ARO-HBV 300 mg | Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers |
| BG004 | ARO-HBV 400 mg | Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers |
| BG005 | Placebo | Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers |
| BG006 | ARO-HBV 25 mg Q28D | ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B |
| BG007 | ARO-HBV 50 mg Q28D | ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B |
| BG008 | ARO-HBV 100 mg Q28D | ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B |
| BG009 | ARO-HBV 200 mg Q28D | ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B |
| BG010 | ARO-HBV 300 mg Q28D | ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B |
| BG011 | ARO-HBV 400 mg Q28D | ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B |
| BG012 | ARO-HBV 100 mg Q14D | ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B |
| BG013 | ARO-HBV 100 mg Q7D | ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B |
| BG014 | ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B |
| BG015 | ARO-HBV 300 mg, Q28D, HBeAg+/NUC | ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B |
| BG016 | ARO-HBV 200 mg, Q7D | ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B |
| BG017 | ARO-HBV 300 mg, Q7D | ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B |
| BG018 | ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B |
| BG019 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | ARO-HBV 100 mg | Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers |
| OG002 | ARO-HBV 200 mg | Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers |
| OG003 | ARO-HBV 300 mg | Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers |
| OG004 | ARO-HBV 400 mg | Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers |
| OG005 | Placebo | Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers |
| OG006 | ARO-HBV 25 mg Q28D | ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB) |
| OG007 | ARO-HBV 50 mg Q28D | ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B |
| OG008 | ARO-HBV 100 mg Q28D | ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B |
| OG009 | ARO-HBV 200 mg Q28D | ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B |
| OG010 | ARO-HBV 300 mg Q28D | ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B |
| OG011 | ARO-HBV 400 mg Q28D | ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B |
| OG012 | ARO-HBV 100 mg Q14D | ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B |
| OG013 | ARO-HBV 100 mg Q7D | ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B |
| OG014 | ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B |
| OG015 | ARO-HBV 300 mg, Q28D, HBeAg+/NUC | ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B |
| OG016 | ARO-HBV 200 mg, Q7D | ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B |
| OG017 | ARO-HBV 300 mg, Q7D | ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B |
| OG018 | ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B |
|
|
| Secondary | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per statistical analysis plan [SAP]). Participants with a valid assessment. | Posted | Mean | Standard Deviation | ng/mL | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Median | Full Range | hours | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t) | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | hours | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | h*ng/mL/mg | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | h*ng/mL/mg | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment. | Posted | Mean | Standard Deviation | ng/mL/mg | Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose |
|
|
|
| Secondary | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | Pharmacodynamic (PD) Population: participants who received at least one dose of study treatment and had PD assessment from baseline and assessment from post-baseline. | Posted | Mean | Standard Deviation | IU/mL | Part B (multiple-ascending dose [MAD] phase) only: up to 113 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | ARO-HBV 100 mg | Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | ARO-HBV 200 mg | Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers | 0 | 4 | 0 | 4 | 3 | 4 |
| EG003 | ARO-HBV 300 mg | Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers | 0 | 4 | 0 | 4 | 3 | 4 |
| EG004 | ARO-HBV 400 mg | Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers | 0 | 4 | 0 | 4 | 3 | 4 |
| EG005 | Placebo | Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers | 0 | 10 | 0 | 10 | 8 | 10 |
| EG006 | ARO-HBV 25 mg Q28D | ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B (CHB) | 0 | 8 | 0 | 8 | 6 | 8 |
| EG007 | ARO-HBV 50 mg Q28D | ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B | 0 | 8 | 0 | 8 | 6 | 8 |
| EG008 | ARO-HBV 100 mg Q28D | ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B | 0 | 8 | 1 | 8 | 5 | 8 |
| EG009 | ARO-HBV 200 mg Q28D | ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B | 0 | 8 | 0 | 8 | 4 | 8 |
| EG010 | ARO-HBV 300 mg Q28D | ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B | 0 | 8 | 0 | 8 | 6 | 8 |
| EG011 | ARO-HBV 400 mg Q28D | ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B | 0 | 8 | 1 | 8 | 7 | 8 |
| EG012 | ARO-HBV 100 mg Q14D | ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B | 0 | 4 | 0 | 4 | 3 | 4 |
| EG013 | ARO-HBV 100 mg Q7D | ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B | 0 | 4 | 0 | 4 | 4 | 4 |
| EG014 | ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | ARO-HBV 300 mg sc injection Q28D in HBeAg+/Treatment Naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B | 0 | 4 | 0 | 4 | 3 | 4 |
| EG015 | ARO-HBV 300 mg, Q28D, HBeAg+/NUC | ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B | 0 | 4 | 0 | 4 | 2 | 4 |
| EG016 | ARO-HBV 200 mg, Q7D | ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B | 0 | 4 | 0 | 4 | 4 | 4 |
| EG017 | ARO-HBV 300 mg, Q7D | ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B | 0 | 4 | 1 | 4 | 3 | 4 |
| EG018 | ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B | 0 | 12 | 1 | 12 | 3 | 12 |
| Retroperitoneal mass | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Vascular access site bruising | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Vascular access site inflammation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site bruise | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral hyperaesthesia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flushing | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Hepatitis C antibody positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Urine uric acid increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ear swelling | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperparathyroidism primary | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Retroperitoneal mass | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Analyte: JNJ-73763924 |
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| Analyte: JNJ-73763924 |
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| Analyte: JNJ-76763924 |
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| Analyte: JNJ-76763924 |
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| Analyte: JNJ-76763924 |
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| Analyte: JNJ-76763924 |
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| Analyte: JNJ-6763924 |
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| Analyte:JNJ-76763924 |
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| Analyte: JNJ-76763924 |
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