Trial Outcomes & Findings for To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses. (NCT NCT01958645)
NCT ID: NCT01958645
Last Updated: 2016-02-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
157 participants
Primary outcome timeframe
From screening and up to the lab follow-up visit (Day 29)
Results posted on
2016-02-04
Participant Flow
Male healthy volunteers recruited by advertisement during the period October 2013 - October 2014
The study was prematurely terminated after 2 cohorts as dose escalation stopping criteria (PD thresholds) were reached and it was judged to be of limited value to expose more healthy subjects. Cohort 1: 2 placebo + 4 MEDI8111 dose 1. Cohort 2: 2 placebo + 4 MEDI8111 dose 2.
Participant milestones
| Measure |
Placebo
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 Participants
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 Participants
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 9 • n=93 Participants
|
30 years
STANDARD_DEVIATION 6 • n=4 Participants
|
30 years
STANDARD_DEVIATION 6 • n=27 Participants
|
29 years
STANDARD_DEVIATION 7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From screening and up to the lab follow-up visit (Day 29)Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 Participants
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 Participants
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
Placebo Dose 2
Placebo dose 2 (Saline solution for infusion)
|
|---|---|---|---|---|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Subjects with any AE
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Gastrointestinal disorders
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Infections and infestations
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Investigations
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Musculoskeletal and connective tissue disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Nervous system disorder
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Respiratory, thoracic and mediastinal disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
Skin and subcutaneous tissue disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Predose and Days 1-5For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 Participants
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 Participants
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
Placebo Dose 2
n=2 Participants
Placebo dose 2 (Saline solution for infusion)
|
|---|---|---|---|---|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
12 h
|
82.5 nM*min
Standard Deviation 70.0
|
366 nM*min
Standard Deviation 396
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
0.98 h
|
16 nM*min
Standard Deviation 143
|
131 nM*min
Standard Deviation 219
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
1.03 h
|
30.5 nM*min
Standard Deviation 138
|
145 nM*min
Standard Deviation 263
|
39.8 nM*min
Standard Deviation 72.1
|
-35.0 nM*min
Standard Deviation 214
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
1.25 h
|
67.0 nM*min
Standard Deviation 356
|
135 nM*min
Standard Deviation 345
|
211 nM*min
Standard Deviation 179
|
27.0 nM*min
Standard Deviation 80.6
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
1.5 h
|
166 nM*min
Standard Deviation 75
|
-17.3 nM*min
Standard Deviation 120
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
2 h
|
32.5 nM*min
Standard Deviation 148
|
178 nM*min
Standard Deviation 336
|
147 nM*min
Standard Deviation 167
|
-79.5 nM*min
Standard Deviation 95.5
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
3 h
|
57.0 nM*min
Standard Deviation 238
|
188 nM*min
Standard Deviation 385
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
4 h
|
-88.0 nM*min
Standard Deviation 226
|
72.8 nM*min
Standard Deviation 545
|
157 nM*min
Standard Deviation 277
|
4.50 nM*min
Standard Deviation 48.8
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
8 h
|
157 nM*min
Standard Deviation 161
|
141 nM*min
Standard Deviation 288
|
83.0 nM*min
Standard Deviation 216
|
6.50 nM*min
Standard Deviation 33.2
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
24 h
|
-29.0 nM*min
Standard Deviation 279
|
115 nM*min
Standard Deviation 336
|
86.0 nM*min
Standard Deviation 120
|
70.5 nM*min
Standard Deviation 14.8
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
36 h
|
-59.0 nM*min
Standard Deviation 134
|
329 nM*min
Standard Deviation 496
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
48 h
|
29.0 nM*min
Standard Deviation 222
|
172 nM*min
Standard Deviation 264
|
206 nM*min
Standard Deviation 261
|
91.0 nM*min
Standard Deviation 26.9
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
72 h
|
183 nM*min
Standard Deviation 222
|
71.5 nM*min
Standard Deviation 274
|
139 nM*min
Standard Deviation 194
|
73.5 nM*min
Standard Deviation 9.19
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
96 h
|
-95.0 nM*min
Standard Deviation 209
|
-1.00 nM*min
Standard Deviation 483
|
64.8 nM*min
Standard Deviation 223
|
46.0 nM*min
Standard Deviation 8.49
|
|
Change From Baseline Endogenous Thrombin Potential (ETP)
Follow up
|
-12.5 nM*min
Standard Deviation 13.4
|
-34.5 nM*min
Standard Deviation 206
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA nM*min
Standard Deviation NA
No sample was planned to be collected at this time point.
|
SECONDARY outcome
Timeframe: Predose and 1-8 hoursOutcome measures
| Measure |
Placebo
n=2 Participants
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 Participants
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 Participants
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
Placebo Dose 2
n=2 Participants
Placebo dose 2 (Saline solution for infusion)
|
|---|---|---|---|---|
|
Change From Baseline Factor II Concentrations by ECL Assay
1 h
|
-0.131 umol/L
Standard Deviation 0.0156
|
-0.0305 umol/L
Standard Deviation 0.0435
|
0.166 umol/L
Standard Deviation 0.0632
|
0.0650 umol/L
Standard Deviation 0.0212
|
|
Change From Baseline Factor II Concentrations by ECL Assay
1.25 h
|
-0.143 umol/L
Standard Deviation 0.00354
|
-0.0920 umol/L
Standard Deviation 0.0881
|
0.116 umol/L
Standard Deviation 0.113
|
0.0600 umol/L
Standard Deviation 0.0424
|
|
Change From Baseline Factor II Concentrations by ECL Assay
4 h
|
-0.127 umol/L
Standard Deviation 0.279
|
0.123 umol/L
Standard Deviation 0.0663
|
0.141 umol/L
Standard Deviation 0.155
|
0.0450 umol/L
Standard Deviation 0.0495
|
|
Change From Baseline Factor II Concentrations by ECL Assay
0.33 h
|
-0.0810 umol/L
Standard Deviation 0.0410
|
-0.0188 umol/L
Standard Deviation 0.0661
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by ECL Assay
0.67 h
|
-0.0480 umol/L
Standard Deviation 0.0113
|
0.0275 umol/L
Standard Deviation 0.0377
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by ECL Assay
0.98 h
|
-0.134 umol/L
Standard Deviation 0.0368
|
0.00450 umol/L
Standard Deviation 0.0896
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by ECL Assay
1.5 h
|
-0.132 umol/L
Standard Deviation 0.121
|
-0.124 umol/L
Standard Deviation 0.148
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by ECL Assay
2 h
|
-0.0655 umol/L
Standard Deviation 0.0629
|
0.00450 umol/L
Standard Deviation 0.188
|
0.111 umol/L
Standard Deviation 0.129
|
0.0800 umol/L
Standard Deviation 0.0849
|
|
Change From Baseline Factor II Concentrations by ECL Assay
3 h
|
-0.0675 umol/L
Standard Deviation 0.248
|
0.0608 umol/L
Standard Deviation 0.120
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA umol/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by ECL Assay
8 h
|
0.00650 umol/L
Standard Deviation 0.122
|
0.0633 umol/L
Standard Deviation 0.0801
|
0.0835 umol/L
Standard Deviation 0.0731
|
-0.00900 umol/L
Standard Deviation 0.0410
|
SECONDARY outcome
Timeframe: Predose and 1-8 hoursOutcome measures
| Measure |
Placebo
n=2 Participants
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 Participants
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 Participants
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
Placebo Dose 2
n=2 Participants
Placebo dose 2 (Saline solution for infusion)
|
|---|---|---|---|---|
|
Change From Baseline Factor II Concentrations by Clot Assay
0.33 h
|
7.65 % (concentration)
Standard Deviation 26.4
|
-1.40 % (concentration)
Standard Deviation 7.67
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by Clot Assay
0.67 h
|
3.15 % (concentration)
Standard Deviation 17.2
|
1.35 % (concentration)
Standard Deviation 6.95
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by Clot Assay
0.98 h
|
-9.35 % (concentration)
Standard Deviation 12.2
|
-2.40 % (concentration)
Standard Deviation 4.25
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by Clot Assay
1 h
|
-14.4 % (concentration)
Standard Deviation 13.6
|
-1.15 % (concentration)
Standard Deviation 4.22
|
13.7 % (concentration)
Standard Deviation 14.5
|
7.30 % (concentration)
Standard Deviation 0.00
|
|
Change From Baseline Factor II Concentrations by Clot Assay
1.25
|
-6.85 % (concentration)
Standard Deviation 18.6
|
-0.400 % (concentration)
Standard Deviation 5.54
|
12.2 % (concentration)
Standard Deviation 9.55
|
8.30 % (concentration)
Standard Deviation 1.41
|
|
Change From Baseline Factor II Concentrations by Clot Assay
1.5 h
|
-10.9 % (concentration)
Standard Deviation 12.9
|
-0.400 % (concentration)
Standard Deviation 8.67
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by Clot Assay
2 h
|
-8.85 % (concentration)
Standard Deviation 8.70
|
0.350 % (concentration)
Standard Deviation 5.45
|
10.5 % (concentration)
Standard Deviation 7.84
|
2.80 % (concentration)
Standard Deviation 4.95
|
|
Change From Baseline Factor II Concentrations by Clot Assay
3 h
|
-5.85 % (concentration)
Standard Deviation 12.9
|
1.10 % (concentration)
Standard Deviation 9.73
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA % (concentration)
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline Factor II Concentrations by Clot Assay
4 h
|
0.150 % (concentration)
Standard Deviation 15.8
|
2.10 % (concentration)
Standard Deviation 4.45
|
18.2 % (concentration)
Standard Deviation 9.02
|
7.30 % (concentration)
Standard Deviation 4.24
|
|
Change From Baseline Factor II Concentrations by Clot Assay
8 h
|
-9.85 % (concentration)
Standard Deviation 10.1
|
-1.90 % (concentration)
Standard Deviation 5.78
|
11.7 % (concentration)
Standard Deviation 9.12
|
9.30 % (concentration)
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: predose and 1-8 hoursOutcome measures
| Measure |
Placebo
n=2 Participants
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 Participants
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 Participants
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
Placebo Dose 2
n=2 Participants
Placebo dose 2 (Saline solution for infusion)
|
|---|---|---|---|---|
|
Change From Baseline D-dimer Concentration
8 h
|
0.588 mg/L
Standard Deviation 0.799
|
0.0858 mg/L
Standard Deviation 0.0914
|
0.0633 mg/L
Standard Deviation 0.0630
|
0.0470 mg/L
Standard Deviation 0.0849
|
|
Change From Baseline D-dimer Concentration
0.98 h
|
-0.0169 mg/L
Standard Deviation 0.0144
|
0.0408 mg/L
Standard Deviation 0.103
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline D-dimer Concentration
1.03 h
|
0.0432 mg/L
Standard Deviation 0.0564
|
0.0383 mg/L
Standard Deviation 0.109
|
0.0108 mg/L
Standard Deviation 0.0190
|
0.0270 mg/L
Standard Deviation 0.0141
|
|
Change From Baseline D-dimer Concentration
1.25 h
|
0.0232 mg/L
Standard Deviation 0.113
|
0.000750 mg/L
Standard Deviation 0.0336
|
0.0333 mg/L
Standard Deviation 0.0306
|
0.0170 mg/L
Standard Deviation 0.0566
|
|
Change From Baseline D-dimer Concentration
1.5 h
|
-0.00185 mg/L
Standard Deviation 0.0214
|
0.408 mg/L
Standard Deviation 0.795
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline D-dimer Concentration
2 h
|
0.0682 mg/L
Standard Deviation 0.135
|
0.0382 mg/L
Standard Deviation 0.0813
|
0.0610 mg/L
Standard Deviation 0.0760
|
0.0170 mg/L
Standard Deviation 0.0424
|
|
Change From Baseline D-dimer Concentration
3 h
|
0.0732 mg/L
Standard Deviation 0.0846
|
0.00325 mg/L
Standard Deviation 0.0237
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
|
Change From Baseline D-dimer Concentration
4 h
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
NA mg/L
Standard Deviation NA
No sample was planned to be collected at this time point.
|
0.0933 mg/L
Standard Deviation 0.0810
|
0.207 mg/L
Standard Deviation 0.0849
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI8111 Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI8111 Dose 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Placebo (Saline solution for infusion)
|
MEDI8111 Dose 1
n=4 participants at risk
MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
|
MEDI8111 Dose 2
n=4 participants at risk
MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
|
Investigations
Fibrin D-dimer increased
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
25.0%
1/4 • At screening, Days 1-5
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
25.0%
1/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
0.00%
0/4 • At screening, Days 1-5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place