- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02085473
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
December 5, 2018 updated by: MedImmune LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Celerion
-
Lincoln, Nebraska, United States, 68502
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Other Names:
|
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.
|
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Other Names:
|
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.
|
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Other Names:
|
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.
|
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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
|
The Cmax is the maximum observed serum concentration of tralokinumab.
|
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
|
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
|
Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.
|
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
|
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
|
AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration.
|
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
|
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
|
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).
|
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
|
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
|
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).
|
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
|
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
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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
|
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.
|
0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection
|
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
|
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.
|
From start of study drug administration up to Day 57
|
Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination
Time Frame: Day 1 to Day 57
|
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.
|
Day 1 to Day 57
|
Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs
Time Frame: Day 1 to Day 57
|
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.
|
Day 1 to Day 57
|
Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
Time Frame: Day 1 to Day 57
|
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.
|
Day 1 to Day 57
|
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
Time Frame: Pre-dose on Day 1 and Day 57
|
Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples.
|
Pre-dose on Day 1 and Day 57
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 19, 2014
Primary Completion (ACTUAL)
July 10, 2014
Study Completion (ACTUAL)
July 10, 2014
Study Registration Dates
First Submitted
March 11, 2014
First Submitted That Met QC Criteria
March 11, 2014
First Posted (ESTIMATE)
March 12, 2014
Study Record Updates
Last Update Posted (ACTUAL)
December 31, 2018
Last Update Submitted That Met QC Criteria
December 5, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2210C00011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Tralokinumab 300 mg
-
MedImmune LLCCompleted
-
MedImmune LLCCompletedAsthmaUnited States, Czech Republic, France, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, United Kingdom, Germany, Philippines, Argentina, Canada, Chile, Japan
-
MedImmune LLCCompletedAsthmaBulgaria, United Kingdom, Germany, Poland, Romania
-
MedImmune LLCCompleted
-
Prof. Dr. Stephan WeidingerCompletedAtopic DermatitisGermany
-
LEO PharmaActive, not recruitingAtopic DermatitisSpain, United Kingdom, Czechia, France, Netherlands
-
Bausch Health Americas, Inc.CompletedRheumatoid ArthritisUnited States
-
Novartis PharmaceuticalsCompletedChronic Plaque PsoriasisUnited States
-
Radboud University Medical CenterUnknownAcute Kidney Injury | Critically Ill ChildrenNetherlands
-
AstraZenecaCompletedAsthmaUnited States, France, Belgium, Germany, Poland, Ukraine, Netherlands