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A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT02085473•MedImmune LLC

View on ClinicalTrials.gov

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

Age

19 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.

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

Locations (2)

Celerion

Lincoln, Nebraska, United States

Research Site

Lincoln, Nebraska, United States

Key Dates

Start Date

March 19, 2014

Primary Completion Date

July 10, 2014

Completion Date

July 10, 2014

Last Updated

December 31, 2018

Enrollment

ACTUAL participants

Conditions

AsthmaHealthy Subjects or Volunteers

Interventions

Tralokinumab 300 mg

BIOLOGICAL

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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RECRUITINGPHASE2

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma