Trial Outcomes & Findings for Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions (NCT NCT03603106)
NCT ID: NCT03603106
Last Updated: 2021-05-14
Results Overview
Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
142 participants
Primary outcome timeframe
From baseline (30 minutes before injection) to 24 hours post-injection
Results posted on
2021-05-14
Participant Flow
For part I, all patients who were not randomized were screening failures. For part II, all patients who were not allocated to a dose of P03277 were screening failures.
Participant milestones
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) Placebo
3 healthy subjects per dose group received placebo in one single administration.
Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) P03277 0.05 mmol/kg
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.075 mmol/kg
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.1 mmol/kg
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.2 mmol/kg
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
18
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Baseline characteristics by cohort
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration.
P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration.
P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration.
P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration.
P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration.
P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration.
P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) Placebo
n=18 Participants
3 healthy subjects per dose group received placebo in one single administration.
Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) P03277 0.05 mmol/kg
n=3 Participants
3 patients received one single administration of P03277.
P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.075 mmol/kg
n=3 Participants
3 patients received one single administration of P03277.
P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.1 mmol/kg
n=3 Participants
3 patients received one single administration of P03277.
P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.2 mmol/kg
n=3 Participants
3 patients received one single administration of P03277.
P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.0 years
n=5 Participants
|
25.5 years
n=7 Participants
|
27.5 years
n=5 Participants
|
25.5 years
n=4 Participants
|
23.0 years
n=21 Participants
|
33.5 years
n=8 Participants
|
26.5 years
n=8 Participants
|
40.0 years
n=24 Participants
|
56.0 years
n=42 Participants
|
56.0 years
n=42 Participants
|
53.0 years
n=42 Participants
|
28.0 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
Weight
|
81.65 kg
n=5 Participants
|
71.60 kg
n=7 Participants
|
65.00 kg
n=5 Participants
|
72.50 kg
n=4 Participants
|
69.30 kg
n=21 Participants
|
72.50 kg
n=8 Participants
|
67.90 kg
n=8 Participants
|
87.20 kg
n=24 Participants
|
80.40 kg
n=42 Participants
|
87.20 kg
n=42 Participants
|
85.80 kg
n=42 Participants
|
72.85 kg
n=42 Participants
|
PRIMARY outcome
Timeframe: From baseline (30 minutes before injection) to 24 hours post-injectionPopulation: In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected). In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).
Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.
Outcome measures
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=5 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) 0.05 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.075 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.1 mmol/kg
n=2 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.2 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter Cmax
|
248.7 µg/mL
Standard Deviation 54.5
|
524.5 µg/mL
Standard Deviation 69.9
|
698.7 µg/mL
Standard Deviation 378.9
|
992.0 µg/mL
Standard Deviation 233.1
|
2097.6 µg/mL
Standard Deviation 572.3
|
3916.4 µg/mL
Standard Deviation 1114.8
|
370.8 µg/mL
Standard Deviation 117.6
|
618.2 µg/mL
Standard Deviation 439.7
|
701.6 µg/mL
Standard Deviation 48.5
|
1434.9 µg/mL
Standard Deviation 651.5
|
PRIMARY outcome
Timeframe: From baseline (30 minutes before injection) to 24 hours post-injectionPopulation: In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected). In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).
T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.
Outcome measures
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=5 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) 0.05 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.075 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.1 mmol/kg
n=2 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.2 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter T1/2
|
1.65 hours
Standard Deviation 0.43
|
1.50 hours
Standard Deviation 0.22
|
1.58 hours
Standard Deviation 0.30
|
1.73 hours
Standard Deviation 0.26
|
1.82 hours
Standard Deviation 0.35
|
2.09 hours
Standard Deviation 0.15
|
1.90 hours
Standard Deviation 0.04
|
2.04 hours
Standard Deviation 0.06
|
1.79 hours
Standard Deviation 0.17
|
1.94 hours
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: From baseline (30 minutes before injection) to 24 hours post-injectionPopulation: In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected). In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).
Cl = total clearance. Blood samples were taken to assess the P03277 concentration.
Outcome measures
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=5 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) 0.05 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.075 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.1 mmol/kg
n=2 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.2 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter Cl
|
91.7 mL/min
Standard Deviation 8.5
|
100.1 mL/min
Standard Deviation 9.5
|
106.4 mL/min
Standard Deviation 20.7
|
96.1 mL/min
Standard Deviation 11.8
|
101.3 mL/min
Standard Deviation 10.9
|
102.2 mL/min
Standard Deviation 19.0
|
105.3 mL/min
Standard Deviation 13.5
|
106.5 mL/min
Standard Deviation 15.7
|
108.6 mL/min
Standard Deviation 5
|
109.9 mL/min
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: From baseline (30 minutes before injection) to 24 hours post-injectionPopulation: In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected). In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).
Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.
Outcome measures
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=5 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 Participants
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) 0.05 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.075 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.1 mmol/kg
n=2 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) 0.2 mmol/kg
n=3 Participants
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter Vd
|
13203 mL
Standard Deviation 4122
|
12945 mL
Standard Deviation 1692
|
14312 mL
Standard Deviation 2742
|
14351 mL
Standard Deviation 2645
|
15922 mL
Standard Deviation 3224
|
18487 mL
Standard Deviation 3575
|
17320 mL
Standard Deviation 1942
|
18796 mL
Standard Deviation 2478
|
16823 mL
Standard Deviation 804
|
18355 mL
Standard Deviation 2522
|
Adverse Events
Part I (Phase I) P03277 0.025 mmol/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I (Phase I) P03277 0.05 mmol/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part I (Phase I) P03277 0.075 mmol/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I (Phase I) P03277 0.1 mmol/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part I (Phase I) P03277 0.2 mmol/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part I (Phase I) P03277 0.3 mmol/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part I (Phase I) Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part II (Phase IIA) P03277 0.05 mmol/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part II (Phase IIA) P03277 0.075 mmol/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part II (Phase IIA) P03277 0.1 mmol/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part II (Phase IIA) P03277 0.2 mmol/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) Placebo
n=18 participants at risk
3 healthy subjects per dose group received placebo in one single administration.
Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) P03277 0.05 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.075 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.1 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.2 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
1/3 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
Other adverse events
| Measure |
Part I (Phase I) P03277 0.025 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.05 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.075 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.1 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.2 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) P03277 0.3 mmol/kg
n=6 participants at risk
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
|
Part I (Phase I) Placebo
n=18 participants at risk
3 healthy subjects per dose group received placebo in one single administration.
Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
|
Part II (Phase IIA) P03277 0.05 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.075 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.1 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
|
Part II (Phase IIA) P03277 0.2 mmol/kg
n=3 participants at risk
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Flushing
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site pain
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
2/6 • Number of events 2 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
3/18 • Number of events 3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
50.0%
3/6 • Number of events 3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
1/3 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site oedema
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Fatigue
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site coldness
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Injection site inflammation
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 2 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
2/6 • Number of events 3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
27.8%
5/18 • Number of events 5 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
1/3 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
1/3 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
1/3 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
33.3%
1/3 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
5.6%
1/18 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
16.7%
1/6 • Number of events 1 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/6 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/18 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
0.00%
0/3 • For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
All adverse events occuring pre- and post-injection are reported below.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER