NCT02085473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 asthma

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_1 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

March 19, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2014

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

November 23, 2018

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

March 11, 2014

Results QC Date

July 21, 2017

Last Update Submit

December 5, 2018

Conditions

AsthmaHealthy Subjects or Volunteers

Keywords

AsthmaHealthy Subjects or VolunteersTralokinumabCAT-354

Outcome Measures

Primary Outcomes (7)

  • Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])

    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)

    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)

    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])

    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)

    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

    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)

    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 Outcomes (7)

  • Local Injection-Site Pain and Injection-Site Pruritus

    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

    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)

    From start of study drug administration up to Day 57

  • Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination

    Day 1 to Day 57

  • Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs

    Day 1 to Day 57

  • +2 more secondary outcomes

Study Arms (4)

Cohort 1

ACTIVE COMPARATOR

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'W' mL/min.

Biological: Tralokinumab 300 mg

Cohort 2

EXPERIMENTAL

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'X' mL/min.

Biological: Tralokinumab 300 mg

Cohort 3

EXPERIMENTAL

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Y' mL/min.

Biological: Tralokinumab 300 mg

Cohort 4

EXPERIMENTAL

Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Z' mL/min.

Biological: Tralokinumab 300 mg

Interventions

Tralokinumab 300 mgBIOLOGICAL

Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.

Also known as: CAT-354
Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Research Site

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

  • 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.

    PMID: 28590244BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Meena Jain
Organization
MedImmune, LLC
jainm@medimmune.com
+44 (0) 1223 895966

Study Officials

  • Barbara Cook, MD

    Celerion

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 12, 2014

Study Start

March 19, 2014

Primary Completion

July 10, 2014

Study Completion

July 10, 2014

Last Updated

December 31, 2018

Results First Posted

November 23, 2018

Record last verified: 2018-12

Locations

US(2)