Trial Outcomes & Findings for Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD) (NCT NCT01037309)
NCT ID: NCT01037309
Last Updated: 2018-10-16
Results Overview
number of subjects with 1 or more treatment emergent adverse events following SC or IV PRO044
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
During the 5 weeks of treatment and during the 13 weeks after treatment
Results posted on
2018-10-16
Participant Flow
3 Subjects were recruited to each of cohorts 1-6 (total n=18) for SC administration PRO044 9 of these 18 subjects were recruited to cohorts 7-9 (n=3 in each cohort) for IV adminstration PRO044
3 Subjects were recruited to each of cohorts 1-6 (total n=18) for SC administration PRO044 9 of these 18 subjects were recruited to cohorts 7-9 (n=3 in each cohort) for IV adminstration PRO044
Participant milestones
| Measure |
Subcutaneous PRO044 0.5 mg/kg
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Subcutaneous PRO044 1.5 mg/kg
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Subcutaneous PRO044 5 mg/kg
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Subcutaneous PRO044 8 mg/kg
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Subcutaneous PRO044 10 mg/kg
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Subcutaneous PRO044 12 mg/kg
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Intravenous PRO044 1.5 mg/kg
Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
Intravenous PRO044 5 mg/kg
Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
Intravenous PRO044 8 mg/kg
Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Subcutaneous Cohort 1 - 6
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
|
Subcutaneous Cohort 1 - 6
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
|
Subcutaneous Cohort 1 - 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intravenous Period 7 - 9
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
|
Intravenous Period 7 - 9
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
|
Intravenous Period 7 - 9
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD)
Baseline characteristics by cohort
| Measure |
PRO044, Cohort 1
n=3 Participants
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 2
n=3 Participants
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 3
n=3 Participants
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 4
n=3 Participants
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 5
n=3 Participants
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 6
n=3 Participants
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
6 participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
7 participants
n=8 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 13 weeks after 5 weeks of treatmentPopulation: For some participants it was not possible to determine dystrophin expression in muscle biopsy
Outcome measures
| Measure |
PRO044, Cohort 1
n=1 Participants
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 2
n=1 Participants
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 3
n=3 Participants
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 4
n=3 Participants
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 5
n=2 Participants
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 6
n=3 Participants
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 7
n=2 Participants
Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 8
n=3 Participants
Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 9
n=3 Participants
Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Increase in Dystrophin Expression in the Muscle Biopsies by Immunofluorescence Analyses of Cross-sections and by Western Blot Analyses of Total Protein Extracts
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 5 weeks of treatment and during the 13 weeks after treatmentnumber of subjects with 1 or more treatment emergent adverse events following SC or IV PRO044
Outcome measures
| Measure |
PRO044, Cohort 1
n=3 Participants
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 2
n=3 Participants
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 3
n=3 Participants
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 4
n=3 Participants
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 5
n=3 Participants
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 6
n=3 Participants
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 7
n=3 Participants
Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 8
n=3 Participants
Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 9
n=3 Participants
Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of PRO044
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 1, Week 5Population: Pharmacokinetic population evaluated
Pharmacokinetic population evaluated for maximum plasma concentration (Cmax)
Outcome measures
| Measure |
PRO044, Cohort 1
n=3 Participants
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 2
n=3 Participants
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 3
n=3 Participants
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 4
n=3 Participants
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 5
n=3 Participants
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 6
n=3 Participants
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 7
n=3 Participants
Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 8
n=3 Participants
Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 9
n=3 Participants
Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
PRO044 Pharmacokinetic Cmax (μg/mL) Following Subcutaneous Administration
Week 1
|
0.4 ug/mL
Geometric Coefficient of Variation 42.5
|
1.6 ug/mL
Geometric Coefficient of Variation 21.7
|
4.2 ug/mL
Geometric Coefficient of Variation 61.5
|
6.2 ug/mL
Geometric Coefficient of Variation 53.8
|
4.9 ug/mL
Geometric Coefficient of Variation 21.7
|
5.2 ug/mL
Geometric Coefficient of Variation 16.0
|
3.1 ug/mL
Geometric Coefficient of Variation 28.9
|
4.7 ug/mL
Geometric Coefficient of Variation 18.9
|
8.7 ug/mL
Geometric Coefficient of Variation 31.3
|
|
PRO044 Pharmacokinetic Cmax (μg/mL) Following Subcutaneous Administration
Week 5
|
0.4 ug/mL
Geometric Coefficient of Variation 28.8
|
1.5 ug/mL
Geometric Coefficient of Variation 22.9
|
3.4 ug/mL
Geometric Coefficient of Variation 31.4
|
5.1 ug/mL
Geometric Coefficient of Variation 24.2
|
4.4 ug/mL
Geometric Coefficient of Variation 7.0
|
4.8 ug/mL
Geometric Coefficient of Variation 35.7
|
2.2 ug/mL
Geometric Coefficient of Variation 20.6
|
3.5 ug/mL
Geometric Coefficient of Variation 69.5
|
8.7 ug/mL
Geometric Coefficient of Variation 33.6
|
Adverse Events
PRO044, Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 7
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PRO044, Cohort 8
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PRO044, Cohort 9
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRO044, Cohort 1
n=3 participants at risk
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 2
n=3 participants at risk
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 3
n=3 participants at risk
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 4
n=3 participants at risk
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 5
n=3 participants at risk
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 6
n=3 participants at risk
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 7
n=3 participants at risk
Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 8
n=3 participants at risk
Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 9
n=3 participants at risk
Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
International normalised ratio increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
activated partial thromboplastin time prolonged
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
orthostatic proteinuria
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
Other adverse events
| Measure |
PRO044, Cohort 1
n=3 participants at risk
Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 2
n=3 participants at risk
Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 3
n=3 participants at risk
Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 4
n=3 participants at risk
Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 5
n=3 participants at risk
Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 6
n=3 participants at risk
Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29
PRO044 SC: Subcutaneous injection, once a week, for five weeks
|
PRO044, Cohort 7
n=3 participants at risk
Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 8
n=3 participants at risk
Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
PRO044, Cohort 9
n=3 participants at risk
Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
PRO044 IV: Intravenous injection, once a week, for five weeks
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site hematoma
|
33.3%
1/3
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
|
General disorders
Injection site erythema
|
0.00%
0/3
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
66.7%
2/3
|
100.0%
3/3
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
|
General disorders
Injection site edema
|
0.00%
0/3
|
0.00%
0/3
|
100.0%
3/3
|
66.7%
2/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Injection site pain
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
66.7%
2/3
|
33.3%
1/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Performance status decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
General disorders
Application site erythema
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Influenza like illness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
|
General disorders
Injection site discoloration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Injection site pruritus
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Injection site urticaria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Injection site induration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Localized edema
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Edema peripheral
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3
|
100.0%
3/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
100.0%
3/3
|
|
Infections and infestations
Influenza
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
33.3%
1/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Hookworm infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Varicella
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3
|
66.7%
2/3
|
66.7%
2/3
|
33.3%
1/3
|
33.3%
1/3
|
66.7%
2/3
|
33.3%
1/3
|
0.00%
0/3
|
100.0%
3/3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
66.7%
2/3
|
66.7%
2/3
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Post procedural edema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Complement factor decreased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
aPTT prolonged
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
INR increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Monocyte count decreased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
RBC urine positive
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Laboratory test abnormal (elevated MCP-1 levels)
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Investigations
Complement factor C3 decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Investigations
Cystatin C increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Investigations
Electrocardiogram T wave amplitude decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
GLDH increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Investigations
WBC count increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
66.7%
2/3
|
66.7%
2/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Myoglobinuria
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Orthostatic proteinuria
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Vascular disorders
Pallor
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60