A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tralokinumab 300 mg

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Healthy Subjects or Volunteers, Tralokinumab, CAT-354

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Celerion
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Maximum Observed Serum Concentration (Cmax)

The Cmax is the maximum observed serum concentration of tralokinumab.

Time to Maximum Concentration (Tmax)

Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.

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.

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).

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).

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.

Secondary Outcome Measures

Local Injection-Site Pain and 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.

Number of Participants Reporting Local Injection-Site Reactions

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.

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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.

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

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.

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

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.

Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters

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.

Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit

Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples.

Full Information

NCT ID

NCT02085473

First Posted

March 11, 2014

Last Updated

December 5, 2018

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT02085473

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

March 19, 2014 (Actual)

Primary Completion Date

July 10, 2014 (Actual)

Study Completion Date

July 10, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Healthy Subjects or Volunteers

Keywords

Asthma, Healthy Subjects or Volunteers, Tralokinumab, CAT-354

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Tralokinumab 300 mg

Other Intervention Name(s)

CAT-354

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame