Trial Outcomes & Findings for A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (NCT NCT02065336)
NCT ID: NCT02065336
Last Updated: 2026-01-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline, through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 253 Cohort 10)
Results posted on
2026-01-13
Participant Flow
No patients were enrolled in Cohorts 8, 11, or 12. Cohort 9 (n=2) and Cohort 10 (n=8) enrolled participants who previously completed treatment in other cohorts.
Participant milestones
| Measure |
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
|
ARC-520 Cohort 5
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
|
ARC-520 Cohort 1
a single intravenous (IV) dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 4
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 9
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study
STARTED
|
10
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Main Study
COMPLETED
|
10
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Main Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
Reasons for withdrawal
| Measure |
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
|
ARC-520 Cohort 5
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
|
ARC-520 Cohort 1
a single intravenous (IV) dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 4
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 9
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Extension Phase
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
Baseline Characteristics
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
Baseline characteristics by cohort
| Measure |
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 6
n=6 Participants
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
|
ARC-520 Cohort 7
n=12 Participants
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
|
Placebo Normal Saline Cohorts 1-5
n=10 Participants
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 8.22 • n=210 Participants
|
43.0 years
STANDARD_DEVIATION 4.15 • n=19 Participants
|
42.0 years
STANDARD_DEVIATION 1.79 • n=123 Participants
|
39.8 years
STANDARD_DEVIATION 2.04 • n=123 Participants
|
39.5 years
STANDARD_DEVIATION 7.23 • n=615 Participants
|
33.3 years
STANDARD_DEVIATION 4.23 • n=20 Participants
|
39.8 years
STANDARD_DEVIATION 10.12 • n=13 Participants
|
44.4 years
STANDARD_DEVIATION 9.09 • n=335 Participants
|
41.4 years
STANDARD_DEVIATION 7.94 • n=451 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=615 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
20 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
5 Participants
n=123 Participants
|
4 Participants
n=615 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=13 Participants
|
8 Participants
n=335 Participants
|
38 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: Baseline, through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 253 Cohort 10)Population: Pharmacodynamic (PD) Population: all participants who received at least 1 dose of study drug and had evaluable data from at least one postdose PD assessment according to the treatment the participants were assigned.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
n=8 Participants
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
n=6 Participants
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
n=12 Participants
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
n=10 Participants
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 57
|
-2813.0 IU/mL
Standard Deviation 2665.97
|
-1536.0 IU/mL
Standard Deviation 1373.46
|
—
|
-1056.7 IU/mL
Standard Deviation 773.69
|
-2330.1 IU/mL
Standard Deviation 1676.50
|
—
|
-22840 IU/mL
Standard Deviation 32239
|
-1370.7 IU/mL
Standard Deviation 872.64
|
-22658.4 IU/mL
Standard Deviation 34292.84
|
156.1 IU/mL
Standard Deviation 527.40
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 85
|
-926.3 IU/mL
Standard Deviation 1406.29
|
-537.5 IU/mL
Standard Deviation 1901.16
|
-670.1 IU/mL
Standard Deviation 1825.99
|
-542.8 IU/mL
Standard Deviation 1815.34
|
-2119.3 IU/mL
Standard Deviation 1717.17
|
—
|
-23305 IU/mL
Standard Deviation 32455
|
-791.0 IU/mL
Standard Deviation 457.04
|
-20827.2 IU/mL
Standard Deviation 31753.76
|
225.4 IU/mL
Standard Deviation 393.81
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 8
|
-2591.2 IU/mL
Standard Deviation 3304.72
|
-1789.8 IU/mL
Standard Deviation 2101.23
|
-928.1 IU/mL
Standard Deviation 1285.26
|
-2179.2 IU/mL
Standard Deviation 3170.68
|
-884.3 IU/mL
Standard Deviation 1296.49
|
—
|
—
|
-1344.0 IU/mL
Standard Deviation 1319.66
|
-20123.8 IU/mL
Standard Deviation 29795.99
|
42.2 IU/mL
Standard Deviation 568.32
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 15
|
-3069.0 IU/mL
Standard Deviation 3923.45
|
-1672.8 IU/mL
Standard Deviation 1892.73
|
-1055.1 IU/mL
Standard Deviation 1900.89
|
-2260.8 IU/mL
Standard Deviation 4022.82
|
-470.8 IU/mL
Standard Deviation 2025.31
|
—
|
—
|
—
|
-22915.6 IU/mL
Standard Deviation 34381.59
|
236.6 IU/mL
Standard Deviation 321.17
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 22
|
-2978.8 IU/mL
Standard Deviation 3536.73
|
-1951.7 IU/mL
Standard Deviation 2819.85
|
-1225.4 IU/mL
Standard Deviation 1967.15
|
-2266.2 IU/mL
Standard Deviation 3868.90
|
-204.3 IU/mL
Standard Deviation 2077.12
|
—
|
—
|
-1553.7 IU/mL
Standard Deviation 1596.05
|
-23872.7 IU/mL
Standard Deviation 35753.39
|
115.1 IU/mL
Standard Deviation 594.38
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 29
|
-2972.8 IU/mL
Standard Deviation 3506.01
|
-1964.3 IU/mL
Standard Deviation 2501.62
|
-579.1 IU/mL
Standard Deviation 352.71
|
-1826.3 IU/mL
Standard Deviation 2618.78
|
93.3 IU/mL
Standard Deviation 2425.68
|
—
|
-22617 IU/mL
Standard Deviation 32653
|
-1532.3 IU/mL
Standard Deviation 1500.40
|
-24148.3 IU/mL
Standard Deviation 36256.02
|
168.8 IU/mL
Standard Deviation 460.59
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 43
|
-3219.8 IU/mL
Standard Deviation 3601.70
|
-1939.7 IU/mL
Standard Deviation 2277.79
|
-1020.1 IU/mL
Standard Deviation 1252.98
|
-1288.8 IU/mL
Standard Deviation 1498.60
|
-1471.8 IU/mL
Standard Deviation 1625.30
|
—
|
—
|
-1566.8 IU/mL
Standard Deviation 1290.46
|
-23932.0 IU/mL
Standard Deviation 35929.80
|
58.3 IU/mL
Standard Deviation 411.60
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 113
|
—
|
—
|
—
|
—
|
—
|
—
|
-23205 IU/mL
Standard Deviation 32362
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 141
|
—
|
—
|
—
|
—
|
—
|
—
|
-23182 IU/mL
Standard Deviation 32379
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 169
|
—
|
—
|
—
|
—
|
—
|
—
|
-26481 IU/mL
Standard Deviation 33649
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 197
|
—
|
—
|
—
|
—
|
—
|
—
|
-30234 IU/mL
Standard Deviation 34097
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 225
|
—
|
—
|
—
|
—
|
—
|
—
|
-1249 IU/mL
Standard Deviation 1273
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 253
|
—
|
—
|
—
|
—
|
—
|
—
|
-643 IU/mL
Standard Deviation 905
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
-19222 IU/mL
Standard Deviation 27217
|
—
|
—
|
—
|
|
Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Day 3
|
-1501.0 IU/mL
Standard Deviation 1930.12
|
-1664.7 IU/mL
Standard Deviation 2375.62
|
-554.8 IU/mL
Standard Deviation 861.86
|
-1194.0 IU/mL
Standard Deviation 2083.72
|
-1003.6 IU/mL
Standard Deviation 949.36
|
—
|
—
|
-948.0 IU/mL
Standard Deviation 1016.31
|
-12401.1 IU/mL
Standard Deviation 17661.02
|
43.3 IU/mL
Standard Deviation 267.60
|
SECONDARY outcome
Timeframe: through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)Population: Safety Population: all participants who received any amount of study drug or placebo, and had at least 1 postdose safety assessment. Data for Cohort 9 was not analyzed or summarized due to limited enrollment.
An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
n=8 Participants
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
n=10 Participants
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
n=6 Participants
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
n=12 Participants
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
n=2 Participants
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any mild TEAE
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any moderate TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAE related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any life-threatening SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE leading to discontinuation of treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 29, Day 85Population: Safety Population: all participants who received any amount of study drug or placebo, and had at least 1 postdose safety assessment.
Bee venom allergy tests were used to assess immunoglobulin E (IgE) in Cohorts 1-7. Analysis values less than 0.35 kU/L were taken as negative.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
n=6 Participants
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
n=12 Participants
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
n=10 Participants
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Negative Bee Venom Allergy Test Results at Baseline, Day 29, and Day 85
Day 85
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
6 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Negative Bee Venom Allergy Test Results at Baseline, Day 29, and Day 85
Baseline
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
6 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Negative Bee Venom Allergy Test Results at Baseline, Day 29, and Day 85
Day 29
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
6 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 2, 3, 8, 15, 22, 29Population: Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=12 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
n=12 Participants
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
n=10 Participants
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 1
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 2
|
0.12 ng/mL
Standard Deviation 0.10
|
-0.91 ng/mL
Standard Deviation 1.59
|
0.06 ng/mL
Standard Deviation 0.05
|
0.06 ng/mL
Standard Deviation 0.08
|
0.13 ng/mL
Standard Deviation 0.08
|
—
|
—
|
0.16 ng/mL
Standard Deviation 0.04
|
-0.31 ng/mL
Standard Deviation 0.89
|
—
|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 3
|
0.12 ng/mL
Standard Deviation 0.63
|
-1.04 ng/mL
Standard Deviation 1.58
|
-0.02 ng/mL
Standard Deviation 0.02
|
-0.06 ng/mL
Standard Deviation 0.09
|
-0.06 ng/mL
Standard Deviation 0.06
|
—
|
—
|
0.15 ng/mL
Standard Deviation 0.03
|
-0.29 ng/mL
Standard Deviation 0.88
|
—
|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 8
|
-0.03 ng/mL
Standard Deviation 0.18
|
-1.01 ng/mL
Standard Deviation 1.60
|
-0.01 ng/mL
Standard Deviation 0.07
|
-0.09 ng/mL
Standard Deviation 0.08
|
-0.09 ng/mL
Standard Deviation 0.13
|
—
|
—
|
0.45 ng/mL
Standard Deviation 0.76
|
-0.30 ng/mL
Standard Deviation 0.90
|
—
|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 15
|
0.00 ng/mL
Standard Deviation 0.18
|
-1.01 ng/mL
Standard Deviation 1.63
|
0.01 ng/mL
Standard Deviation 0.05
|
-0.03 ng/mL
Standard Deviation 0.12
|
-0.03 ng/mL
Standard Deviation 0.06
|
—
|
—
|
0.32 ng/mL
Standard Deviation 0.11
|
-0.10 ng/mL
Standard Deviation 1.14
|
—
|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 22
|
0.00 ng/mL
Standard Deviation 0.13
|
-1.00 ng/mL
Standard Deviation 1.58
|
0.04 ng/mL
Standard Deviation 0.06
|
-0.02 ng/mL
Standard Deviation 0.14
|
-0.03 ng/mL
Standard Deviation 0.09
|
—
|
—
|
0.33 ng/mL
Standard Deviation 0.11
|
-0.30 ng/mL
Standard Deviation 0.89
|
—
|
|
Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Day 29
|
0.00 ng/mL
Standard Deviation 0.15
|
-1.00 ng/mL
Standard Deviation 1.61
|
0.00 ng/mL
Standard Deviation 0.06
|
-0.01 ng/mL
Standard Deviation 0.11
|
0.01 ng/mL
Standard Deviation 0.07
|
—
|
—
|
0.36 ng/mL
Standard Deviation 0.11
|
-0.30 ng/mL
Standard Deviation 0.89
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24), Cohorts 1-5
AD0009
|
318 µg*hr/mL
Standard Deviation 82.3
|
349 µg*hr/mL
Standard Deviation 45.2
|
79.1 µg*hr/mL
Standard Deviation 8.28
|
185 µg*hr/mL
Standard Deviation 61.2
|
212 µg*hr/mL
Standard Deviation 34.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24), Cohorts 1-5
AD0010
|
370 µg*hr/mL
Standard Deviation 80.5
|
412 µg*hr/mL
Standard Deviation 47.5
|
93.0 µg*hr/mL
Standard Deviation 9.11
|
190 µg*hr/mL
Standard Deviation 43.2
|
301 µg*hr/mL
Standard Deviation 43.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Cohorts 1-5
AD0009
|
326 µg*hr/mL
Standard Deviation 87.3
|
356 µg*hr/mL
Standard Deviation 47.4
|
81.4 µg*hr/mL
Standard Deviation 9.25
|
196 µg*hr/mL
Standard Deviation 66.3
|
218 µg*hr/mL
Standard Deviation 37.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Cohorts 1-5
AD0010
|
385 µg*hr/mL
Standard Deviation 88.0
|
434 µg*hr/mL
Standard Deviation 53.3
|
97.6 µg*hr/mL
Standard Deviation 9.77
|
205 µg*hr/mL
Standard Deviation 50.2
|
317 µg*hr/mL
Standard Deviation 50.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Cohorts 1-5 Only
AD0009
|
326 µg*hr/mL
Standard Deviation 87.4
|
356 µg*hr/mL
Standard Deviation 47.4
|
81.4 µg*hr/mL
Standard Deviation 9.26
|
196 µg*hr/mL
Standard Deviation 66.3
|
218 µg*hr/mL
Standard Deviation 37.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Cohorts 1-5 Only
AD0010
|
386 µg*hr/mL
Standard Deviation 88.6
|
435 µg*hr/mL
Standard Deviation 53.8
|
97.8 µg*hr/mL
Standard Deviation 9.80
|
207 µg*hr/mL
Standard Deviation 51.1
|
318 µg*hr/mL
Standard Deviation 51.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Maximum Observed Plasma Concentration (Cmax), Cohorts 1-5
AD0009
|
54.8 µg/mL
Standard Deviation 9.59
|
58.2 µg/mL
Standard Deviation 5.88
|
13.7 µg/mL
Standard Deviation 2.42
|
26.4 µg/mL
Standard Deviation 6.84
|
33.5 µg/mL
Standard Deviation 1.78
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Maximum Observed Plasma Concentration (Cmax), Cohorts 1-5
AD0010
|
50.5 µg/mL
Standard Deviation 10.6
|
52.4 µg/mL
Standard Deviation 6.44
|
12.7 µg/mL
Standard Deviation 2.07
|
22.5 µg/mL
Standard Deviation 2.74
|
39.7 µg/mL
Standard Deviation 2.60
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Clearance (CL), Cohorts 1-5
AD0009
|
6.47 mL/hr/kg
Standard Deviation 1.51
|
5.70 mL/hr/kg
Standard Deviation 0.781
|
6.21 mL/hr/kg
Standard Deviation 0.724
|
5.58 mL/hr/kg
Standard Deviation 1.84
|
7.11 mL/hr/kg
Standard Deviation 1.56
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Clearance (CL), Cohorts 1-5
AD0010
|
5.41 mL/hr/kg
Standard Deviation 1.19
|
4.65 mL/hr/kg
Standard Deviation 0.586
|
5.16 mL/hr/kg
Standard Deviation 0.522
|
5.08 mL/hr/kg
Standard Deviation 1.19
|
4.84 mL/hr/kg
Standard Deviation 0.952
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Apparent Volume of Distribution During the Terminal Phase (Vz), Cohorts 1-5
AD0009
|
39.0 mL/kg
Standard Deviation 7.27
|
35.4 mL/kg
Standard Deviation 4.06
|
39.5 mL/kg
Standard Deviation 4.13
|
43.2 mL/kg
Standard Deviation 15.8
|
45.7 mL/kg
Standard Deviation 5.72
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Apparent Volume of Distribution During the Terminal Phase (Vz), Cohorts 1-5
AD0010
|
37.9 mL/kg
Standard Deviation 5.83
|
36.9 mL/kg
Standard Deviation 3.18
|
39.4 mL/kg
Standard Deviation 5.01
|
46.1 mL/kg
Standard Deviation 9.99
|
37.1 mL/kg
Standard Deviation 2.52
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Volume in Steady State (Vss), Cohorts 1-5
AD0009
|
39.6 mL/kg
Standard Deviation 6.31
|
35.3 mL/kg
Standard Deviation 3.57
|
39.6 mL/kg
Standard Deviation 6.05
|
45.8 mL/kg
Standard Deviation 11.6
|
45.3 mL/kg
Standard Deviation 3.60
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Volume in Steady State (Vss), Cohorts 1-5
AD0010
|
39.8 mL/kg
Standard Deviation 6.36
|
38.5 mL/kg
Standard Deviation 4.21
|
40.7 mL/kg
Standard Deviation 6.01
|
46.7 mL/kg
Standard Deviation 8.22
|
38.1 mL/kg
Standard Deviation 2.08
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Rate Constant (Kel), Cohorts 1-5
AD0009
|
0.165 1/hr
Standard Deviation 0.0120
|
0.161 1/hr
Standard Deviation 0.00614
|
0.157 1/hr
Standard Deviation 0.0115
|
0.132 1/hr
Standard Deviation 0.0242
|
0.154 1/hr
Standard Deviation 0.0135
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Rate Constant (Kel), Cohorts 1-5
AD0010
|
0.142 1/hr
Standard Deviation 0.0164
|
0.126 1/hr
Standard Deviation 0.00793
|
0.132 1/hr
Standard Deviation 0.0131
|
0.111 1/hr
Standard Deviation 0.0188
|
0.130 1/hr
Standard Deviation 0.0180
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
ARC-520 Cohort 4
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 1
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 Participants
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 10
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
ARC-520 Cohort 6
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
Placebo Normal Saline Cohorts 1-5
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Half-Life (t1/2), Cohorts 1-5
AD0009
|
4.18 hours
Interval 3.92 to 4.87
|
4.32 hours
Interval 4.14 to 4.6
|
4.38 hours
Interval 4.06 to 4.96
|
5.36 hours
Interval 4.16 to 7.0
|
4.64 hours
Interval 3.87 to 4.9
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Half-Life (t1/2), Cohorts 1-5
AD0010
|
4.79 hours
Interval 4.32 to 6.15
|
5.36 hours
Interval 5.16 to 6.02
|
5.29 hours
Interval 4.76 to 6.19
|
6.32 hours
Interval 5.09 to 7.94
|
5.48 hours
Interval 4.26 to 6.41
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
ARC-520 Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ARC-520 Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARC-520 Cohort 5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 7
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 9
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 10
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Normal Saline Cohorts 1-5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARC-520 Cohort 1
n=6 participants at risk
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 2
n=6 participants at risk
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 3
n=6 participants at risk
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 4
n=6 participants at risk
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
|
ARC-520 Cohort 5
n=6 participants at risk
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
|
ARC-520 Cohort 6
n=6 participants at risk
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
|
ARC-520 Cohort 7
n=12 participants at risk
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
|
ARC-520 Cohort 9
n=2 participants at risk
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
|
ARC-520 Cohort 10
n=8 participants at risk
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
|
Placebo Normal Saline Cohorts 1-5
n=10 participants at risk
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
8.3%
1/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
62.5%
5/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
62.5%
5/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
General disorders
Malaise
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
50.0%
1/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
25.0%
2/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
16.7%
1/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/6 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/12 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/2 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
12.5%
1/8 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
0.00%
0/10 • From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place