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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02085473 |
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Date of registration:
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11/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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March 19, 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02085473 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Barbara Cook, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Celerion |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Healthy males and females ages 19-65 years
- 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.
Key Exclusion Criteria:
- Concurrent enrollment in another clinical study where the subject is receiving an
investigational product
- 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
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Healthy Subjects or Volunteers
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Intervention(s)
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Biological: Tralokinumab 300 mg
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Primary Outcome(s)
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Time to Maximum Concentration (Tmax)
[Time Frame: 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]
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Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
[Time Frame: 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]
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Apparent Terminal-Phase Volume of Distribution (Vz/F)
[Time Frame: 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]
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Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
[Time Frame: 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]
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Maximum Observed Serum Concentration (Cmax)
[Time Frame: 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]
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Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
[Time Frame: 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]
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Terminal Elimination Half-life (t1/2)
[Time Frame: 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]
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Secondary Outcome(s)
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Number of Participants Reporting Local Injection-Site Reactions
[Time Frame: 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection]
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Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
[Time Frame: Day 1 to Day 57]
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Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs
[Time Frame: Day 1 to Day 57]
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Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
[Time Frame: Pre-dose on Day 1 and Day 57]
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
[Time Frame: From start of study drug administration up to Day 57]
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Local Injection-Site Pain and Injection-Site Pruritus
[Time Frame: During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus]
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Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination
[Time Frame: Day 1 to Day 57]
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Secondary ID(s)
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D2210C00011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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