Trial Outcomes & Findings for Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers (NCT NCT02968914)
NCT ID: NCT02968914
Last Updated: 2019-07-05
Results Overview
To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
180 participants
Primary outcome timeframe
At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Results posted on
2019-07-05
Participant Flow
Subjects who met all the inclusion and none of the exclusion criteria were enrolled at PAREXEL Early Phase Clinical Unit in Berlin and London.
Subjects attended a Screening Visit within 28 days before receiving their first dose of Benralizumab. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.
Participant milestones
| Measure |
Benralizumab 30mg Autoinjector (AI)
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
90
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Benralizumab 30mg Autoinjector (AI)
n=90 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
n=90 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.8 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
41.1 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
40.9 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices
Outcome measures
| Measure |
Benralizumab 30mg AI
n=88 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=87 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)
|
72210 day·ng/mL
Geometric Coefficient of Variation 29.7
|
76220 day·ng/mL
Geometric Coefficient of Variation 32.1
|
PRIMARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices
Outcome measures
| Measure |
Benralizumab 30mg AI
n=90 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=90 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
|
60560 day·ng/mL
Geometric Coefficient of Variation 27.3
|
65230 day·ng/mL
Geometric Coefficient of Variation 29.2
|
PRIMARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices
Outcome measures
| Measure |
Benralizumab 30mg AI
n=90 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=90 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
2096 ng/mL
Geometric Coefficient of Variation 32.7
|
2269 ng/mL
Geometric Coefficient of Variation 35.4
|
SECONDARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges
Outcome measures
| Measure |
Benralizumab 30mg AI
n=90 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=90 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Time When Maximum Concentration is Observed (Tmax)
Abdomen 55.0 to 69.9 kg
|
4.59 Days
Interval 2.97 to 7.04
|
6.06 Days
Interval 4.0 to 14.0
|
|
Time When Maximum Concentration is Observed (Tmax)
Abdomen 70.0 to 84.9 kg
|
6.98 Days
Interval 3.98 to 14.0
|
5.98 Days
Interval 2.95 to 14.05
|
|
Time When Maximum Concentration is Observed (Tmax)
Abdomen 85.0 to 100.0 kg
|
5.06 Days
Interval 3.95 to 7.11
|
6.96 Days
Interval 3.99 to 7.1
|
|
Time When Maximum Concentration is Observed (Tmax)
Thigh 55.0 to 69.9 kg
|
4.00 Days
Interval 2.97 to 7.01
|
4.52 Days
Interval 2.94 to 7.04
|
|
Time When Maximum Concentration is Observed (Tmax)
Thigh 70.0 to 84.9 kg
|
4.05 Days
Interval 2.98 to 6.9
|
3.52 Days
Interval 2.95 to 7.12
|
|
Time When Maximum Concentration is Observed (Tmax)
Thigh 85.0 to 100.0 kg
|
4.59 Days
Interval 2.94 to 13.95
|
4.03 Days
Interval 2.98 to 6.98
|
|
Time When Maximum Concentration is Observed (Tmax)
Upper arm 55.0 to 69.9 kg
|
6.97 Days
Interval 3.97 to 14.02
|
4.96 Days
Interval 3.02 to 14.04
|
|
Time When Maximum Concentration is Observed (Tmax)
Upper arm 70.0 to 84.9 kg
|
7.00 Days
Interval 5.01 to 14.03
|
5.02 Days
Interval 2.99 to 8.01
|
|
Time When Maximum Concentration is Observed (Tmax)
Upper arm 85.0 to 100.0 kg
|
7.00 Days
Interval 3.09 to 14.03
|
6.97 Days
Interval 1.02 to 14.13
|
SECONDARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.
To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Outcome measures
| Measure |
Benralizumab 30mg AI
n=88 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=87 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Terminal Half-life (t½)
Upper arm 70.0 to 84.9 kg
|
20.54 Days
Geometric Coefficient of Variation 14.0
|
20.16 Days
Geometric Coefficient of Variation 25.3
|
|
Terminal Half-life (t½)
Upper arm 85.0 to 100.0 kg
|
19.01 Days
Geometric Coefficient of Variation 26.9
|
19.42 Days
Geometric Coefficient of Variation 26.3
|
|
Terminal Half-life (t½)
Abdomen 55.0 to 69.9 kg
|
18.83 Days
Geometric Coefficient of Variation 24.9
|
20.15 Days
Geometric Coefficient of Variation 21.8
|
|
Terminal Half-life (t½)
Abdomen 70.0 to 84.9 kg
|
20.22 Days
Geometric Coefficient of Variation 21.0
|
17.43 Days
Geometric Coefficient of Variation 21.7
|
|
Terminal Half-life (t½)
Abdomen 85.0 to 100.0 kg
|
19.59 Days
Geometric Coefficient of Variation 19.9
|
21.04 Days
Geometric Coefficient of Variation 21.7
|
|
Terminal Half-life (t½)
Thigh 55.0 to 69.9 kg
|
18.58 Days
Geometric Coefficient of Variation 20.6
|
19.72 Days
Geometric Coefficient of Variation 21.4
|
|
Terminal Half-life (t½)
Thigh 70.0 to 84.9 kg
|
19.93 Days
Geometric Coefficient of Variation 23.4
|
18.28 Days
Geometric Coefficient of Variation 17.9
|
|
Terminal Half-life (t½)
Thigh 85.0 to 100.0 kg
|
19.02 Days
Geometric Coefficient of Variation 19.9
|
17.30 Days
Geometric Coefficient of Variation 11.5
|
|
Terminal Half-life (t½)
Upper arm 55.0 to 69.9 kg
|
22.46 Days
Geometric Coefficient of Variation 13.6
|
17.30 Days
Geometric Coefficient of Variation 26.9
|
SECONDARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.
To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Outcome measures
| Measure |
Benralizumab 30mg AI
n=88 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=87 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Apparent Extravascular Clearance (CL/F)
Abdomen 55.0 to 69.9 kg
|
388.8 mL/day
Geometric Coefficient of Variation 34.3
|
388.9 mL/day
Geometric Coefficient of Variation 43.8
|
|
Apparent Extravascular Clearance (CL/F)
Abdomen 70.0 to 84.9 kg
|
462.9 mL/day
Geometric Coefficient of Variation 29.5
|
508.9 mL/day
Geometric Coefficient of Variation 33.2
|
|
Apparent Extravascular Clearance (CL/F)
Abdomen 85.0 to 100.0 kg
|
504.6 mL/day
Geometric Coefficient of Variation 18.3
|
402.7 mL/day
Geometric Coefficient of Variation 30.4
|
|
Apparent Extravascular Clearance (CL/F)
Thigh 55.0 to 69.9 kg
|
350.1 mL/day
Geometric Coefficient of Variation 32.6
|
281.1 mL/day
Geometric Coefficient of Variation 16.8
|
|
Apparent Extravascular Clearance (CL/F)
Thigh 70.0 to 84.9 kg
|
393.7 mL/day
Geometric Coefficient of Variation 29.6
|
325.9 mL/day
Geometric Coefficient of Variation 18.2
|
|
Apparent Extravascular Clearance (CL/F)
Thigh 85.0 to 100.0 kg
|
378.2 mL/day
Geometric Coefficient of Variation 26.8
|
406.0 mL/day
Geometric Coefficient of Variation 22.9
|
|
Apparent Extravascular Clearance (CL/F)
Upper arm 55.0 to 69.9 kg
|
345.8 mL/day
Geometric Coefficient of Variation 24.7
|
455.2 mL/day
Geometric Coefficient of Variation 29.8
|
|
Apparent Extravascular Clearance (CL/F)
Upper arm 70.0 to 84.9 kg
|
429.4 mL/day
Geometric Coefficient of Variation 19.5
|
366.1 mL/day
Geometric Coefficient of Variation 27.0
|
|
Apparent Extravascular Clearance (CL/F)
Upper arm 85.0 to 100.0 kg
|
532.6 mL/day
Geometric Coefficient of Variation 21.7
|
471.6 mL/day
Geometric Coefficient of Variation 20.3
|
SECONDARY outcome
Timeframe: At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.
To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Outcome measures
| Measure |
Benralizumab 30mg AI
n=88 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=87 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Upper arm 85.0 to 100.0 kg
|
14.61 Liters
Geometric Coefficient of Variation 23.0
|
13.21 Liters
Geometric Coefficient of Variation 32.9
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Abdomen 55.0 to 69.9 kg
|
10.56 Liters
Geometric Coefficient of Variation 28.0
|
11.30 Liters
Geometric Coefficient of Variation 28.4
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Abdomen 70.0 to 84.9 kg
|
13.50 Liters
Geometric Coefficient of Variation 30.4
|
12.79 Liters
Geometric Coefficient of Variation 25.5
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Abdomen 85.0 to 100.0 kg
|
14.26 Liters
Geometric Coefficient of Variation 25.0
|
12.22 Liters
Geometric Coefficient of Variation 15.8
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Thigh 55.0 to 69.9 kg
|
9.386 Liters
Geometric Coefficient of Variation 18.2
|
7.999 Liters
Geometric Coefficient of Variation 15.5
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Thigh 70.0 to 84.9 kg
|
11.32 Liters
Geometric Coefficient of Variation 23.5
|
8.596 Liters
Geometric Coefficient of Variation 13.5
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Thigh 85.0 to 100.0 kg
|
10.38 Liters
Geometric Coefficient of Variation 20.2
|
10.13 Liters
Geometric Coefficient of Variation 21.0
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Upper arm 55.0 to 69.9 kg
|
11.21 Liters
Geometric Coefficient of Variation 21.2
|
11.36 Liters
Geometric Coefficient of Variation 17.7
|
|
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Upper arm 70.0 to 84.9 kg
|
12.72 Liters
Geometric Coefficient of Variation 23.6
|
10.65 Liters
Geometric Coefficient of Variation 18.7
|
SECONDARY outcome
Timeframe: At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57Population: Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.
To evaluate safety and tolerability of Benralizumab
Outcome measures
| Measure |
Benralizumab 30mg AI
n=90 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=90 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Number of Participants With Adverse Events
Any AE
|
50 Participants
|
46 Participants
|
|
Number of Participants With Adverse Events
Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Any SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Any AE leading to discontinuation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At predose (Day 1), Days 29 and 57Population: Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.
To evaluate the immunogenicity of Benralizumab
Outcome measures
| Measure |
Benralizumab 30mg AI
n=90 Participants
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg AFPS
n=90 Participants
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Antidrug Antibody (ADA) Status
ADA prevalence (positive at any visit)
|
2 Participants
|
6 Participants
|
|
Antidrug Antibody (ADA) Status
ADA incidence
|
0 Participants
|
3 Participants
|
Adverse Events
Benralizumab 30mg Autoinjector (AI)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benralizumab 30mg Autoinjector (AI)
n=90 participants at risk
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
|
Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
n=90 participants at risk
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.0%
18/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
14.4%
13/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Infections and infestations
Rhinitis
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Infections and infestations
Gingivitis
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Infections and infestations
Myringitis
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
7/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
12.2%
11/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
5.6%
5/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Nervous system disorders
Headache
|
15.6%
14/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
5.6%
5/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Nervous system disorders
Dizziness
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Nervous system disorders
Syncope
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Nervous system disorders
Tension headache
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Toothache
|
4.4%
4/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
3.3%
3/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
3/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
3/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Musculoskeletal and connective tissue disorders
Tendon discomfort
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Fatigue
|
5.6%
5/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Influenza like illness
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Asthenia
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Discomfort
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Feeling hot
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Injection site hypersensitivity
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
General disorders
Pyrexia
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Vascular disorders
Haematoma
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
2.2%
2/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Psychiatric disorders
Listless
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Eye disorders
Eye pruritus
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Eye disorders
Eye swelling
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Cardiac disorders
Cardiovascular symptom
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Cardiac disorders
Palpitations
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Investigations
Body temperature increased
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
0.00%
0/90 • At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER