A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
NCT ID: NCT02085473
Last Updated: 2018-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2014-03-19
2014-07-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Tralokinumab 300 mg
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
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.
Tralokinumab 300 mg
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
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.
Tralokinumab 300 mg
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
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.
Tralokinumab 300 mg
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Interventions
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Tralokinumab 300 mg
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index of 19.0-30.0 kilogram per meter square (kg/m\^2)
* No clinically significant abnormality
* Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
* Negative alcohol and drug screens
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
* Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception.
Exclusion Criteria
* Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
* Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
* Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
* History of thrombocytopenia or bleeding disorder or use of anticoagulants
* History of any immunodeficiency disorder or use of immunosuppressive medication.
* History of a clinically significant infection
* History of cancer
* Positive Hepatitis B or C
* Positive HIV
19 Years
65 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Cook, MD
Role: PRINCIPAL_INVESTIGATOR
Celerion
Locations
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Celerion
Lincoln, Nebraska, United States
Research Site
Lincoln, Nebraska, United States
Countries
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References
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Jain M, Doughty D, Clawson C, Li X, White N, Agoram B, van der Merwe R. Tralokinumab pharmacokinetics and tolerability when administered by different subcutaneous injection methods and rates . Int J Clin Pharmacol Ther. 2017 Jul;55(7):606-620. doi: 10.5414/CP203023.
Related Links
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Other Identifiers
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D2210C00011
Identifier Type: -
Identifier Source: org_study_id