Trial Outcomes & Findings for A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (NCT NCT02535416)
NCT ID: NCT02535416
Last Updated: 2026-01-13
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
post-dose through the end of study (Day 15 ± 1 day) plus 30 days
Results posted on
2026-01-13
Participant Flow
Participant milestones
| Measure |
ARC-520 Cohort 1
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
4
|
4
|
4
|
4
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
2
|
4
|
4
|
4
|
4
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
ARC-520 Cohort 1
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Family bereavement overseas
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=2 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
n=6 Participants
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
n=6 Participants
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
23.10 Years
STANDARD_DEVIATION 1.49 • n=9 Participants
|
25.96 Years
STANDARD_DEVIATION 7.83 • n=6 Participants
|
29.02 Years
STANDARD_DEVIATION 13.89 • n=9 Participants
|
27.36 Years
STANDARD_DEVIATION 4.91 • n=205 Participants
|
30.05 Years
STANDARD_DEVIATION 9.78 • n=16 Participants
|
28.73 Years
STANDARD_DEVIATION 11.15 • n=82 Participants
|
28.03 Years
STANDARD_DEVIATION 7.79 • n=83 Participants
|
31.19 Years
STANDARD_DEVIATION 11.06 • n=576 Participants
|
31.87 Years
STANDARD_DEVIATION 8.86 • n=415 Participants
|
28.75 Years
STANDARD_DEVIATION 8.74 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
2 Participants
n=83 Participants
|
5 Participants
n=576 Participants
|
1 Participants
n=415 Participants
|
21 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
4 Participants
n=83 Participants
|
1 Participants
n=576 Participants
|
5 Participants
n=415 Participants
|
19 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=576 Participants
|
0 Participants
n=415 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
1 Participants
n=83 Participants
|
1 Participants
n=576 Participants
|
1 Participants
n=415 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=576 Participants
|
0 Participants
n=415 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=576 Participants
|
0 Participants
n=415 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
4 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
4 Participants
n=83 Participants
|
5 Participants
n=576 Participants
|
4 Participants
n=415 Participants
|
31 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=576 Participants
|
1 Participants
n=415 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=83 Participants
|
0 Participants
n=576 Participants
|
0 Participants
n=415 Participants
|
3 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: post-dose through the end of study (Day 15 ± 1 day) plus 30 daysPopulation: Safety Population: all enrolled participants
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=2 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
n=6 Participants
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
n=6 Participants
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
3 participants
|
2 participants
|
5 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one pharmacokinetic (PK) sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting hepatitis B virus \[HBV\]) and melittin-like peptide (MLP).
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520
Analyte AD0009
|
350027 ng.hr/mL
Standard Deviation 120570
|
331953 ng.hr/mL
Standard Deviation 58196
|
403247 ng.hr/mL
Standard Deviation 72519
|
605608 ng.hr/mL
Standard Deviation 98952
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520
Analyte AD0010
|
411580 ng.hr/mL
Standard Deviation 131789
|
393161 ng.hr/mL
Standard Deviation 64540
|
431980 ng.hr/mL
Standard Deviation 69927
|
630774 ng.hr/mL
Standard Deviation 87136
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520
Analyte MLP
|
839718 ng.hr/mL
Standard Deviation 181756
|
832929 ng.hr/mL
Standard Deviation 132093
|
1015503 ng.hr/mL
Standard Deviation 150276
|
1364108 ng.hr/mL
Standard Deviation 137352
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520
Analyte AD0009
|
361611 ng.hr/mL
Standard Deviation 124315
|
340430 ng.hr/mL
Standard Deviation 61108
|
416905 ng.hr/mL
Standard Deviation 79670
|
638203 ng.hr/mL
Standard Deviation 115032
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520
Analyte AD0010
|
433632 ng.hr/mL
Standard Deviation 139292
|
422964 ng.hr/mL
Standard Deviation 72513
|
461601 ng.hr/mL
Standard Deviation 84332
|
698567 ng.hr/mL
Standard Deviation 107649
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520
Analyte MLP
|
1022752 ng.hr/mL
Standard Deviation 178706
|
1021005 ng.hr/mL
Standard Deviation 191504
|
1270330 ng.hr/mL
Standard Deviation 195274
|
1722485 ng.hr/mL
Standard Deviation 212539
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520
Analyte AD0009
|
361820 ng.hr/mL
Standard Deviation 124381
|
340591 ng.hr/mL
Standard Deviation 61237
|
417153 ng.hr/mL
Standard Deviation 79832
|
638965 ng.hr/mL
Standard Deviation 115557
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520
Analyte AD0010
|
434351 ng.hr/mL
Standard Deviation 139573
|
425598 ng.hr/mL
Standard Deviation 77283
|
462837 ng.hr/mL
Standard Deviation 85266
|
703886 ng.hr/mL
Standard Deviation 111074
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520
Analyte MLP
|
1068557 ng.hr/mL
Standard Deviation 160050
|
1080995 ng.hr/mL
Standard Deviation 218046
|
1368448 ng.hr/mL
Standard Deviation 207758
|
1869597 ng.hr/mL
Standard Deviation 282272
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520
Analyte AD0009
|
54150 ng/mL
Standard Deviation 15711
|
48880 ng/mL
Standard Deviation 6155
|
56350 ng/mL
Standard Deviation 7516
|
73017 ng/mL
Standard Deviation 8532
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520
Analyte AD0010
|
49650 ng/mL
Standard Deviation 14058
|
46220 ng/mL
Standard Deviation 5497
|
49233 ng/mL
Standard Deviation 7088
|
64033 ng/mL
Standard Deviation 8944
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520
Analyte MLP
|
76600 ng/mL
Standard Deviation 19616
|
75500 ng/mL
Standard Deviation 6631
|
85467 ng/mL
Standard Deviation 9382
|
112050 ng/mL
Standard Deviation 13863
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520
Analyte AD0009
|
12.01 mL/hr/kg
Standard Deviation 3.77
|
12.04 mL/hr/kg
Standard Deviation 2.05
|
12.40 mL/hr/kg
Standard Deviation 2.64
|
9.68 mL/hr/kg
Standard Deviation 1.93
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520
Analyte AD0010
|
9.92 mL/hr/kg
Standard Deviation 3.00
|
9.61 mL/hr/kg
Standard Deviation 1.44
|
11.13 mL/hr/kg
Standard Deviation 2.17
|
8.72 mL/hr/kg
Standard Deviation 1.50
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520
Analyte MLP
|
3.80 mL/hr/kg
Standard Deviation 0.51
|
3.85 mL/hr/kg
Standard Deviation 0.91
|
3.73 mL/hr/kg
Standard Deviation 0.58
|
3.27 mL/hr/kg
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520
Analyte AD0009
|
70.02 mL/kg
Standard Deviation 19.42
|
69.31 mL/kg
Standard Deviation 8.53
|
71.49 mL/kg
Standard Deviation 9.40
|
62.74 mL/kg
Standard Deviation 9.28
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520
Analyte AD0010
|
65.98 mL/kg
Standard Deviation 18.44
|
71.62 mL/kg
Standard Deviation 4.74
|
79.68 mL/kg
Standard Deviation 8.52
|
76.21 mL/kg
Standard Deviation 12.89
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520
Analyte MLP
|
58.03 mL/kg
Standard Deviation 17.64
|
55.77 mL/kg
Standard Deviation 7.25
|
63.92 mL/kg
Standard Deviation 9.85
|
56.49 mL/kg
Standard Deviation 8.36
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520
Analyte AD0009
|
0.170 1/hr
Standard Deviation 0.027
|
0.170 1/hr
Standard Deviation 0.012
|
0.172 1/hr
Standard Deviation 0.019
|
0.155 1/hr
Standard Deviation 0.021
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520
Analyte AD0010
|
0.150 1/hr
Standard Deviation 0.027
|
0.134 1/hr
Standard Deviation 0.025
|
0.140 1/hr
Standard Deviation 0.022
|
0.117 1/hr
Standard Deviation 0.023
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520
Analyte MLP
|
0.068 1/hr
Standard Deviation 0.015
|
0.070 1/hr
Standard Deviation 0.022
|
0.057 1/hr
Standard Deviation 0.008
|
0.058 1/hr
Standard Deviation 0.013
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose through 48 hours post-dosePopulation: All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Outcome measures
| Measure |
ARC-520 Cohort 1
n=4 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=5 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
ARC-520 Cohort 2
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=6 Participants
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 6
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520
Analyte AD0009
|
4.10 hour
Standard Deviation 0.73
|
4.02 hour
Standard Deviation 0.30
|
4.06 hour
Standard Deviation 0.44
|
4.56 hour
Standard Deviation 0.69
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520
Analyte AD0010
|
4.68 hour
Standard Deviation 1.03
|
5.31 hour
Standard Deviation 1.23
|
5.07 hour
Standard Deviation 0.85
|
6.17 hour
Standard Deviation 1.34
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520
Analyte MLP
|
10.41 hour
Standard Deviation 2.01
|
10.44 hour
Standard Deviation 2.29
|
11.94 hour
Standard Deviation 1.32
|
12.24 hour
Standard Deviation 2.77
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
ARC-520 Cohort 6
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ARC-520 Cohort 7
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARC-520 Cohort 8
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ARC-520 Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARC-520 Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ARC-520 Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARC-520 Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ARC-520 Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ARC-520 Cohort 2A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARC-520 Cohort 6
n=6 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine
|
ARC-520 Cohort 7
n=6 participants at risk
Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 8
n=6 participants at risk
Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 4
n=4 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine
|
ARC-520 Cohort 5
n=4 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine
|
ARC-520 Cohort 2
n=4 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine
|
ARC-520 Cohort 3
n=4 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine
|
ARC-520 Cohort 1
n=4 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine
|
ARC-520 Cohort 2A
n=2 participants at risk
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest discomfort
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Gastrointestinal disorders
Abdomial discomfort
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
General disorders
Chills
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
General disorders
Fatigue
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
100.0%
2/2 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
General disorders
General symptom
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
General disorders
Malaise
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Infections and infestations
Injection site pustule
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
100.0%
2/2 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Investigations
Aspartate aminotrasferase increased
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
33.3%
2/6 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
2/4 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
100.0%
2/2 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
50.0%
1/2 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
100.0%
2/2 • Number of events 2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Vascular disorders
Haematoma
|
16.7%
1/6 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/6 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
25.0%
1/4 • Number of events 1 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/4 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
0.00%
0/2 • post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place