A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
Study identifier:D2210C00011
ClinicalTrials.gov identifier:NCT02085473
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Tralokinumab When Delivered as a 2 mL Injection at Different Flow Rates to Healthy Volunteers
Medical condition
asthma, Healthy Subjects or Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
-
Sex
All
Actual Enrollment
60
Study type
Interventional
Age
19 Years - 65 Years
Date
Study Start Date: 19 Mar 2014
Primary Completion Date: 10 Jul 2014
Study Completion Date: 10 Jul 2014
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Nov 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Cohort 1 Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'W' mL/min. | Biological/Vaccine: Tralokinumab 300 mg Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates. Other Name: CAT-354 |
| Experimental: Cohort 2 Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'X' mL/min. | Biological/Vaccine: Tralokinumab 300 mg Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates. Other Name: CAT-354 |
| Experimental: Cohort 3 Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Y' mL/min. | Biological/Vaccine: Tralokinumab 300 mg Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates. Other Name: CAT-354 |
| Experimental: Cohort 4 Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Z' mL/min. | Biological/Vaccine: Tralokinumab 300 mg Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates. Other Name: CAT-354 |
Contacts
Investigators
Principal Investigator
Barbara Cook
Celerion
