Clinical trial NCT02085473: A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Healthy Subjects or Volunteers
Keywords: Asthma
Healthy Subjects or Volunteers
Tralokinumab
CAT-354
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.

Detailed description: This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
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
measure: Maximum Observed Serum Concentration (Cmax)
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
measure: Time to Maximum Concentration (Tmax)
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
measure: Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
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
measure: Terminal Elimination Half-life (t1/2)
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
measure: Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
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
measure: Apparent Terminal-Phase Volume of Distribution (Vz/F)
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
Secondary outcomes:
measure: Local Injection-Site Pain and Injection-Site Pruritus
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 pruritus
measure: Number of Participants Reporting Local Injection-Site Reactions
timeFrame: 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: From start of study drug administration up to Day 57
measure: Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination
timeFrame: Day 1 to Day 57
measure: Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs
timeFrame: Day 1 to Day 57
measure: Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
timeFrame: Day 1 to Day 57
measure: Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
timeFrame: Pre-dose on Day 1 and Day 57
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
Study officials:
affiliation: Celerion
name: Barbara Cook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.