Hepatitis B
Conditions
Brief summary
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).
Interventions
DRUGARO-HBV
sc injection
OTHERSterile Normal Saline (0.9% NaCl)
sc injection
DRUGJNJ-56136379
oral tablets
Sponsors
Arrowhead Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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: * Diagnosis of chronic HBV infection * Hepatitis B surface antigen (HbsAg) at screening \> or = 50 IU/mL * Liver Elastography score \< or = 10.5
Exclusion criteria
* Clinically significant health concerns (with the exception of HBV for Patients in Part B) * Abnormal for any clinical safety laboratory result considered clinically significant * Regular use of alcohol within 1 month prior to screening * Recent use of illicit drugs * Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study NOTE: additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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, 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: 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 |
| 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 |
Countries
Australia, Hong Kong, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARO-HBV 35 mg Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers | 4 |
| ARO-HBV 100 mg Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers | 4 |
| ARO-HBV 200 mg Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers | 4 |
| ARO-HBV 300 mg Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers | 4 |
| ARO-HBV 400 mg Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers | 4 |
| Placebo Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers | 10 |
| ARO-HBV 25 mg Q28D ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B | 8 |
| ARO-HBV 50 mg Q28D ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B | 8 |
| ARO-HBV 100 mg Q28D ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B | 8 |
| ARO-HBV 200 mg Q28D ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B | 8 |
| ARO-HBV 300 mg Q28D ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B | 8 |
| ARO-HBV 400 mg Q28D ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B | 8 |
| ARO-HBV 100 mg Q14D ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B | 4 |
| ARO-HBV 100 mg Q7D ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B | 4 |
| 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 | 4 |
| 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 | 4 |
| ARO-HBV 200 mg, Q7D ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B | 4 |
| ARO-HBV 300 mg, Q7D ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B | 4 |
| 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 | 12 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | ARO-HBV 35 mg | Total | ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | ARO-HBV 300 mg, Q7D | ARO-HBV 200 mg, Q7D | ARO-HBV 300 mg, Q28D, HBeAg+/NUC | ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | ARO-HBV 100 mg Q7D | ARO-HBV 100 mg Q14D | ARO-HBV 400 mg Q28D | ARO-HBV 300 mg Q28D | ARO-HBV 200 mg Q28D | ARO-HBV 100 mg Q28D | ARO-HBV 50 mg Q28D | ARO-HBV 25 mg Q28D | Placebo | ARO-HBV 400 mg | ARO-HBV 300 mg | ARO-HBV 200 mg | ARO-HBV 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 22.0 years STANDARD_DEVIATION 3.01 | 40.3 years STANDARD_DEVIATION 12.7 | 44.9 years STANDARD_DEVIATION 9.19 | 50.7 years STANDARD_DEVIATION 12.39 | 53.2 years STANDARD_DEVIATION 6.67 | 36.0 years STANDARD_DEVIATION 4.93 | 31.8 years STANDARD_DEVIATION 7.9 | 40.7 years STANDARD_DEVIATION 6.59 | 48.9 years STANDARD_DEVIATION 7.71 | 41.0 years STANDARD_DEVIATION 9.91 | 52.1 years STANDARD_DEVIATION 7.42 | 47.5 years STANDARD_DEVIATION 6.75 | 50.8 years STANDARD_DEVIATION 12.48 | 47.8 years STANDARD_DEVIATION 6.97 | 42.8 years STANDARD_DEVIATION 7.17 | 27.2 years STANDARD_DEVIATION 9.08 | 23.6 years STANDARD_DEVIATION 3.73 | 28.1 years STANDARD_DEVIATION 8.15 | 24.8 years STANDARD_DEVIATION 4.23 | 23.5 years STANDARD_DEVIATION 0.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 74 Participants | 12 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 3 Participants | 6 Participants | 5 Participants | 8 Participants | 8 Participants | 6 Participants | 6 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 13 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 21 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants | 3 Participants | 3 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 42 Participants | 4 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 6 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 72 Participants | 8 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 6 Participants | 8 Participants | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 12 |
| other Total, other adverse events | 1 / 4 | 4 / 4 | 3 / 4 | 3 / 4 | 3 / 4 | 8 / 10 | 6 / 8 | 6 / 8 | 5 / 8 | 4 / 8 | 6 / 8 | 7 / 8 | 3 / 4 | 4 / 4 | 3 / 4 | 2 / 4 | 4 / 4 | 3 / 4 | 3 / 12 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 8 | 0 / 8 | 1 / 8 | 0 / 8 | 0 / 8 | 1 / 8 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 1 / 4 | 1 / 12 |
Outcome results
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.
Time frame: NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)
Population: Safety Population: all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARO-HBV 35 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| ARO-HBV 35 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 100 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| ARO-HBV 100 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 200 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| ARO-HBV 200 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| ARO-HBV 300 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 1 Participants |
| ARO-HBV 400 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 400 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 5 Participants |
| ARO-HBV 25 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 2 Participants |
| ARO-HBV 25 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 1 Participants |
| ARO-HBV 50 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 2 Participants |
| ARO-HBV 50 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 100 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 100 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| ARO-HBV 200 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 1 Participants |
| ARO-HBV 200 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 1 Participants |
| ARO-HBV 300 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 5 Participants |
| ARO-HBV 300 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 2 Participants |
| ARO-HBV 400 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 3 Participants |
| ARO-HBV 400 mg Q28D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 2 Participants |
| ARO-HBV 100 mg Q14D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 0 Participants |
| ARO-HBV 100 mg Q14D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 100 mg Q7D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 2 Participants |
| ARO-HBV 100 mg Q7D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 2 Participants |
| ARO-HBV 300 mg, Q28D, HBeAg+/Trt Naïve | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 2 Participants |
| ARO-HBV 300 mg, Q28D, HBeAg+/NUC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 0 Participants |
| ARO-HBV 300 mg, Q28D, HBeAg+/NUC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 1 Participants |
| ARO-HBV 200 mg, Q7D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 0 Participants |
| ARO-HBV 200 mg, Q7D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
| ARO-HBV 300 mg, Q7D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 0 Participants |
| ARO-HBV 300 mg, Q7D | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 2 Participants |
| ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Possibly Related TEAE | 0 Participants |
| ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Probably Related TEAE | 0 Participants |
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
Time frame: Part B (multiple-ascending dose [MAD] phase) only: up to 113 days
Population: Pharmacodynamic (PD) Population: participants who received at least one dose of study treatment and had PD assessment from baseline and assessment from post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARO-HBV 35 mg | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.083 IU/mL | Standard Deviation 0.532 |
| ARO-HBV 100 mg | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.199 IU/mL | Standard Deviation 0.2525 |
| ARO-HBV 200 mg | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.695 IU/mL | Standard Deviation 0.4921 |
| ARO-HBV 300 mg | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.769 IU/mL | Standard Deviation 0.4018 |
| ARO-HBV 400 mg | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.534 IU/mL | Standard Deviation 0.308 |
| Placebo | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.889 IU/mL | Standard Deviation 0.6948 |
| ARO-HBV 25 mg Q28D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.549 IU/mL | Standard Deviation 0.2956 |
| ARO-HBV 50 mg Q28D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.412 IU/mL | Standard Deviation 0.4153 |
| ARO-HBV 100 mg Q28D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -2.252 IU/mL | Standard Deviation 1.0177 |
| ARO-HBV 200 mg Q28D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -2.492 IU/mL | Standard Deviation 0.6493 |
| ARO-HBV 300 mg Q28D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -2.316 IU/mL | Standard Deviation 0.6979 |
| ARO-HBV 400 mg Q28D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.879 IU/mL | Standard Deviation 0.2676 |
| ARO-HBV 100 mg Q14D | Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV | -1.687 IU/mL | Standard Deviation 0.3887 |
Secondary
Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763976 | 160 ng/mL | Standard Deviation 106 |
| ARO-HBV 35 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763924 | 43.0 ng/mL | Standard Deviation 25.8 |
| ARO-HBV 100 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763976 | 536 ng/mL | Standard Deviation 390 |
| ARO-HBV 100 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763924 | 117 ng/mL | Standard Deviation 45.2 |
| ARO-HBV 200 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763976 | 1320 ng/mL | Standard Deviation 331 |
| ARO-HBV 200 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763924 | 363 ng/mL | Standard Deviation 89.5 |
| ARO-HBV 300 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763924 | 827 ng/mL | Standard Deviation 447 |
| ARO-HBV 300 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763976 | 2920 ng/mL | Standard Deviation 1670 |
| ARO-HBV 400 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763976 | 4280 ng/mL | Standard Deviation 1340 |
| ARO-HBV 400 mg | Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) | Analyte: JNJ-73763924 | 1010 ng/mL | Standard Deviation 398 |
Secondary
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763976 | 1830 h*ng/mL | Standard Deviation 1190 |
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763924 | 327 h*ng/mL | — |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763976 | 5480 h*ng/mL | Standard Deviation 2540 |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763924 | 1250 h*ng/mL | Standard Deviation 330 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763976 | 17800 h*ng/mL | Standard Deviation 4180 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763924 | 4320 h*ng/mL | Standard Deviation 965 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763924 | 8140 h*ng/mL | Standard Deviation 3160 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763976 | 35500 h*ng/mL | Standard Deviation 17200 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763976 | 44600 h*ng/mL | Standard Deviation 15100 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) | Analyte: JNJ-76763924 | 9720 h*ng/mL | Standard Deviation 3680 |
Secondary
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-76763924 | 365 h*ng/mL | — |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-6763976 | 5820 h*ng/mL | — |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-76763924 | 1530 h*ng/mL | — |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-6763976 | 12600 h*ng/mL | — |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-76763924 | 4610 h*ng/mL | Standard Deviation 1190 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-6763976 | 14800 h*ng/mL | — |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) | Analyte: JNJ-76763924 | 8170 h*ng/mL | Standard Deviation 3420 |
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)
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | 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) | Analyte: JNJ-76763976 | 1830 h*ng/mL | Standard Deviation 1190 |
| ARO-HBV 35 mg | 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) | Analyte: JNJ-76763924 | 254 h*ng/mL | Standard Deviation 127 |
| ARO-HBV 100 mg | 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) | Analyte: JNJ-76763976 | 5740 h*ng/mL | Standard Deviation 2480 |
| ARO-HBV 100 mg | 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) | Analyte: JNJ-76763924 | 1250 h*ng/mL | Standard Deviation 330 |
| ARO-HBV 200 mg | 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) | Analyte: JNJ-76763976 | 20100 h*ng/mL | Standard Deviation 5250 |
| ARO-HBV 200 mg | 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) | Analyte: JNJ-76763924 | 4600 h*ng/mL | Standard Deviation 1130 |
| ARO-HBV 300 mg | 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) | Analyte: JNJ-76763924 | 8330 h*ng/mL | Standard Deviation 2820 |
| ARO-HBV 300 mg | 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) | Analyte: JNJ-76763976 | 37900 h*ng/mL | Standard Deviation 16900 |
| ARO-HBV 400 mg | 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) | Analyte: JNJ-76763976 | 46900 h*ng/mL | Standard Deviation 17400 |
| ARO-HBV 400 mg | 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) | Analyte: JNJ-76763924 | 9940 h*ng/mL | Standard Deviation 3990 |
Secondary
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: NJ-76763976 | 52.1 h*ng/mL/mg | Standard Deviation 34.1 |
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: JNJ-6763924 | 9.34 h*ng/mL/mg | — |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: NJ-76763976 | 54.8 h*ng/mL/mg | Standard Deviation 25.4 |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: JNJ-6763924 | 12.5 h*ng/mL/mg | Standard Deviation 3.3 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: NJ-76763976 | 88.9 h*ng/mL/mg | Standard Deviation 20.9 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: JNJ-6763924 | 21.6 h*ng/mL/mg | Standard Deviation 4.83 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: JNJ-6763924 | 27.1 h*ng/mL/mg | Standard Deviation 10.5 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: NJ-76763976 | 118 h*ng/mL/mg | Standard Deviation 57.3 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: NJ-76763976 | 111 h*ng/mL/mg | Standard Deviation 37.7 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 | Analyte: JNJ-6763924 | 24.3 h*ng/mL/mg | Standard Deviation 9.2 |
Secondary
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte: JNJ-6763976 | 52.1 h*ng/mL/mg | Standard Deviation 34.1 |
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte:JNJ-76763924 | 7.25 h*ng/mL/mg | Standard Deviation 3.63 |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte: JNJ-6763976 | 57.4 h*ng/mL/mg | Standard Deviation 24.8 |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte:JNJ-76763924 | 12.5 h*ng/mL/mg | Standard Deviation 3.3 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte: JNJ-6763976 | 101 h*ng/mL/mg | Standard Deviation 26.3 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte:JNJ-76763924 | 23.0 h*ng/mL/mg | Standard Deviation 5.65 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte:JNJ-76763924 | 27.8 h*ng/mL/mg | Standard Deviation 9.39 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte: JNJ-6763976 | 126 h*ng/mL/mg | Standard Deviation 56.5 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte: JNJ-6763976 | 117 h*ng/mL/mg | Standard Deviation 43.5 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t | Analyte:JNJ-76763924 | 24.8 h*ng/mL/mg | Standard Deviation 9.98 |
Secondary
Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763976 | 4.56 ng/mL/mg | Standard Deviation 3.03 |
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763924 | 1.23 ng/mL/mg | Standard Deviation 0.737 |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763976 | 5.36 ng/mL/mg | Standard Deviation 3.9 |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763924 | 1.17 ng/mL/mg | Standard Deviation 0.452 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763976 | 6.58 ng/mL/mg | Standard Deviation 1.65 |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763924 | 1.81 ng/mL/mg | Standard Deviation 0.448 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763924 | 2.76 ng/mL/mg | Standard Deviation 1.49 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763976 | 9.72 ng/mL/mg | Standard Deviation 5.58 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763976 | 10.7 ng/mL/mg | Standard Deviation 3.34 |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax | Analyte: JNJ-76763924 | 2.53 ng/mL/mg | Standard Deviation 0.994 |
Secondary
Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-76763924 | 7.52 hours | — |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-6763976 | 6.45 hours | — |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-76763924 | 5.97 hours | — |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-6763976 | 5.83 hours | — |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-76763924 | 6.48 hours | Standard Deviation 1.23 |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-6763976 | 9.16 hours | — |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) | Analyte: JNJ-76763924 | 6.02 hours | Standard Deviation 2.34 |
Secondary
Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Population: PK Population: All NHV participants receiving ARO-HBV (participants receiving placebo were excluded from the analysis per SAP). Participants with a valid assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763976 | 6.00 hours |
| ARO-HBV 35 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763924 | 6.00 hours |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763976 | 6.00 hours |
| ARO-HBV 100 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763924 | 6.00 hours |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763976 | 6.00 hours |
| ARO-HBV 200 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763924 | 1.50 hours |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763924 | 2.02 hours |
| ARO-HBV 300 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763976 | 6.03 hours |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763976 | 6.00 hours |
| ARO-HBV 400 mg | Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) | Analyte: JNJ-73763924 | 6.00 hours |