Trial Outcomes & Findings for A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers (NCT NCT02085473)
NCT ID: NCT02085473
Last Updated: 2018-12-31
Results Overview
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day\*micrograms per millilitres = day\*mcg/mL.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Results posted on
2018-12-31
Participant Flow
This study was conducted between 19Mar2014 and 10Jul2014.
A total of 149 participants were screened for the study, out of which 60 participants were randomized and completed in the study.
Participant milestones
| Measure |
Cohort 1
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
38.5 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
38.4 Years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
38.3 Years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The Pharmacokinetic (PK) population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day\*micrograms per millilitres = day\*mcg/mL.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
|
1426.47 day*mcg/mL
Geometric Coefficient of Variation 30.12
|
1243.28 day*mcg/mL
Geometric Coefficient of Variation 25.78
|
1251.63 day*mcg/mL
Geometric Coefficient of Variation 45.46
|
897.02 day*mcg/mL
Geometric Coefficient of Variation 39.13
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
The Cmax is the maximum observed serum concentration of tralokinumab.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
41.65 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 28.20
|
34.07 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 19.64
|
36.12 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 35.69
|
27.04 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 33.86
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax)
|
8 day
Interval 4.0 to 15.0
|
6 day
Interval 4.0 to 10.0
|
8 day
Interval 4.0 to 10.0
|
6 day
Interval 4.0 to 10.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
AUC \[0-t\] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
|
1154.91 day*mcg/mL
Geometric Coefficient of Variation 25.92
|
998.08 day*mcg/mL
Geometric Coefficient of Variation 21.87
|
1013.98 day*mcg/mL
Geometric Coefficient of Variation 41.40
|
685.66 day*mcg/mL
Geometric Coefficient of Variation 35.85
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2)
|
21.62 day
Geometric Coefficient of Variation 26.34
|
22.00 day
Geometric Coefficient of Variation 24.11
|
21.91 day
Geometric Coefficient of Variation 19.31
|
20.61 day
Geometric Coefficient of Variation 20.74
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
|
210.31 milliliters per day (mL/day)
Geometric Coefficient of Variation 33.39
|
241.30 milliliters per day (mL/day)
Geometric Coefficient of Variation 29.16
|
239.69 milliliters per day (mL/day)
Geometric Coefficient of Variation 44.34
|
334.44 milliliters per day (mL/day)
Geometric Coefficient of Variation 355.50
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dosePopulation: The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=14 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Apparent Terminal-Phase Volume of Distribution (Vz/F)
|
6559.99 milliliters (mL)
Geometric Coefficient of Variation 29.85
|
7657.96 milliliters (mL)
Geometric Coefficient of Variation 30.13
|
7577.56 milliliters (mL)
Geometric Coefficient of Variation 35.17
|
9944.14 milliliters (mL)
Geometric Coefficient of Variation 355.40
|
SECONDARY outcome
Timeframe: During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritusPopulation: As-treated population included all participants who were randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Local injection-site pain and pruritus intensity was rated on 0 to 100 millimeter (mm) visual analogue scale (VAS) at various time points, where 0 = no pain/ no pruritus; 100 = most severe pain/ most severe pruritus. Injection site pruritus intensity was assessed by the blinded assessor. Higher the score indicated higher intensity of pain and pruritus. Local injection site pain and pruritus was assessed at below time-points: 1 and 6 minute (min) during investigational product administration (IPA); immediately post IPA, 10, 20, 30, and 60 min, 2, 4, 8, 24 and 72 hour (h) post IPA.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:1 min during IPA
|
—
|
—
|
—
|
6.7 millimole (mmol)
Standard Deviation 12.9
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:6 min during IPA
|
—
|
—
|
—
|
4.8 millimole (mmol)
Standard Deviation 5.9
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain: Immediately Post IPA
|
21.9 millimole (mmol)
Standard Deviation 20.9
|
41.0 millimole (mmol)
Standard Deviation 27.7
|
17.7 millimole (mmol)
Standard Deviation 15.5
|
5.1 millimole (mmol)
Standard Deviation 8.0
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:10 min Post IPA
|
6.9 millimole (mmol)
Standard Deviation 13.9
|
7.1 millimole (mmol)
Standard Deviation 7.7
|
9.5 millimole (mmol)
Standard Deviation 16.3
|
1.3 millimole (mmol)
Standard Deviation 1.3
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:20 min Post IPA
|
2.3 millimole (mmol)
Standard Deviation 5.0
|
3.7 millimole (mmol)
Standard Deviation 7.6
|
1.8 millimole (mmol)
Standard Deviation 2.6
|
1.2 millimole (mmol)
Standard Deviation 1.3
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:30 min Post IPA
|
0.7 millimole (mmol)
Standard Deviation 1.0
|
1.3 millimole (mmol)
Standard Deviation 1.4
|
1.3 millimole (mmol)
Standard Deviation 2.2
|
1.2 millimole (mmol)
Standard Deviation 1.3
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:60 min Post IPA
|
0.7 millimole (mmol)
Standard Deviation 1.0
|
1.1 millimole (mmol)
Standard Deviation 1.5
|
0.7 millimole (mmol)
Standard Deviation 1.0
|
1.2 millimole (mmol)
Standard Deviation 1.2
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:2h Post IPA
|
0.3 millimole (mmol)
Standard Deviation 0.6
|
0.9 millimole (mmol)
Standard Deviation 1.3
|
0.8 millimole (mmol)
Standard Deviation 1.0
|
0.9 millimole (mmol)
Standard Deviation 1.6
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:4h Post IPA
|
0.5 millimole (mmol)
Standard Deviation 0.7
|
0.9 millimole (mmol)
Standard Deviation 1.6
|
0.7 millimole (mmol)
Standard Deviation 0.9
|
1.0 millimole (mmol)
Standard Deviation 1.5
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:8h Post IPA
|
0.5 millimole (mmol)
Standard Deviation 0.7
|
0.7 millimole (mmol)
Standard Deviation 1.4
|
0.5 millimole (mmol)
Standard Deviation 0.7
|
1.1 millimole (mmol)
Standard Deviation 1.6
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:24h Post IPA
|
0.4 millimole (mmol)
Standard Deviation 0.6
|
0.7 millimole (mmol)
Standard Deviation 1.6
|
0.4 millimole (mmol)
Standard Deviation 0.6
|
0.9 millimole (mmol)
Standard Deviation 1.4
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pain:72h Post IPA
|
0.6 millimole (mmol)
Standard Deviation 0.8
|
1.1 millimole (mmol)
Standard Deviation 1.7
|
0.5 millimole (mmol)
Standard Deviation 0.8
|
0.8 millimole (mmol)
Standard Deviation 1.2
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:Immediately Post IPA
|
4.8 millimole (mmol)
Standard Deviation 7.5
|
15.1 millimole (mmol)
Standard Deviation 20.2
|
4.0 millimole (mmol)
Standard Deviation 5.6
|
6.9 millimole (mmol)
Standard Deviation 15.5
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:10 min Post IPA
|
0.9 millimole (mmol)
Standard Deviation 0.9
|
3.1 millimole (mmol)
Standard Deviation 3.8
|
1.9 millimole (mmol)
Standard Deviation 2.3
|
4.1 millimole (mmol)
Standard Deviation 11.1
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:20 min Post IPA
|
0.7 millimole (mmol)
Standard Deviation 0.8
|
1.9 millimole (mmol)
Standard Deviation 2.0
|
1.5 millimole (mmol)
Standard Deviation 1.5
|
2.5 millimole (mmol)
Standard Deviation 3.8
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:30 min Post IPA
|
0.5 millimole (mmol)
Standard Deviation 0.7
|
1.1 millimole (mmol)
Standard Deviation 1.4
|
0.9 millimole (mmol)
Standard Deviation 1.3
|
1.8 millimole (mmol)
Standard Deviation 1.8
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:60 min Post IPA
|
0.6 millimole (mmol)
Standard Deviation 0.8
|
1.0 millimole (mmol)
Standard Deviation 1.9
|
0.7 millimole (mmol)
Standard Deviation 1.0
|
1.3 millimole (mmol)
Standard Deviation 1.1
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:2h Post IPA
|
0.4 millimole (mmol)
Standard Deviation 0.6
|
0.7 millimole (mmol)
Standard Deviation 1.3
|
0.7 millimole (mmol)
Standard Deviation 1.0
|
0.8 millimole (mmol)
Standard Deviation 1.3
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:4h Post IPA
|
0.6 millimole (mmol)
Standard Deviation 0.7
|
0.8 millimole (mmol)
Standard Deviation 1.4
|
0.6 millimole (mmol)
Standard Deviation 0.7
|
0.9 millimole (mmol)
Standard Deviation 1.4
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:8h Post IPA
|
0.4 millimole (mmol)
Standard Deviation 0.6
|
1.1 millimole (mmol)
Standard Deviation 1.8
|
0.7 millimole (mmol)
Standard Deviation 0.6
|
1.2 millimole (mmol)
Standard Deviation 2.0
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:24h Post IPA
|
0.6 millimole (mmol)
Standard Deviation 0.7
|
0.6 millimole (mmol)
Standard Deviation 1.5
|
0.3 millimole (mmol)
Standard Deviation 0.6
|
0.7 millimole (mmol)
Standard Deviation 1.3
|
|
Local Injection-Site Pain and Injection-Site Pruritus
Pruritus:72h Post IPA
|
0.5 millimole (mmol)
Standard Deviation 0.8
|
1.0 millimole (mmol)
Standard Deviation 1.4
|
0.6 millimole (mmol)
Standard Deviation 1.0
|
0.7 millimole (mmol)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injectionPopulation: As-treated population included all participants who were randomized and received any study drug.
The signs and/or symptoms of local injection-site reactions including erythema, hematoma or bleeding, local warmth, swelling, and/or rash occurring within 72 hours post-injection were assessed and recorded by a blinded assessor.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Injection-Site Reactions
Rash
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Injection-Site Reactions
Erythema
|
7 Participants
|
5 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Injection-Site Reactions
Hematoma or bleeding
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Injection-Site Reactions
Local warmth
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Injection-Site Reactions
Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Injection-Site Reactions
Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to Day 57Population: As-treated population included all participants who were randomized and received any study drug.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and important medical event. Treatment-emergent were events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: As-treated population included all participants who were randomized and received any study drug.
The treatment-emergent adverse events related to physical examination were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: As-treated population included all participants who were randomized and received any study drug.
Vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature. The treatment-emergent adverse events related to vital signs were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: As-treated population included all participants who were randomized and received any study drug.
Laboratory parameters included hematology, serum chemistry and urinalysis. The treatment-emergent adverse events in laboratory parameters were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
Serum Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and Day 57Population: As-treated population included all participants who were randomized and received any study drug.
Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 Participants
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=15 participants at risk
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min.
|
Cohort 2
n=15 participants at risk
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min.
|
Cohort 3
n=15 participants at risk
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min.
|
Cohort 4
n=15 participants at risk
Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Day 1 to Day 57
|
13.3%
2/15 • Number of events 3 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
General disorders
Fatigue
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
General disorders
Injection site pain
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
20.0%
3/15 • Number of events 3 • Day 1 to Day 57
|
20.0%
3/15 • Number of events 3 • Day 1 to Day 57
|
20.0%
3/15 • Number of events 3 • Day 1 to Day 57
|
|
Nervous system disorders
Sinus headache
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
13.3%
2/15 • Number of events 2 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
13.3%
2/15 • Number of events 2 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/15 • Day 1 to Day 57
|
13.3%
2/15 • Number of events 2 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Skin and subcutaneous tissue disorders
Scab
|
6.7%
1/15 • Number of events 1 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 2 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
0.00%
0/15 • Day 1 to Day 57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER