Status:
COMPLETED
A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects
Lead Sponsor:
LEO Pharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this trial is to compare the pharmacokinetics (PK), safety, tolerability and immunogenicity of a single dose of 300 mg tralokinumab administered as a 1 × X mL subcutaneous (SC) injectio...
Detailed Description
This is a single center, randomized, open label, 2 period, 2 sequence cross over trial designed to compare the PK and to evaluate the safety, tolerability and immunogenicity of 300 mg tralokinumab adm...
Eligibility Criteria
Inclusion
- Healthy male or female aged 18 to 55 years (both included) at the time of Screening.
- Female subjects of childbearing potential must use a highly effective form of birth control throughout the trial and at least for 16 weeks after last administration of the investigational medicinal product (IMP) and must have a negative serum pregnancy test at Screening.
Exclusion
- Systemic (non biologic) or topical treatment within 21 days prior to first dose administration unless in the opinion of the Investigator the medication will not interfere with the trial procedures or compromise safety.
- Active tuberculosis or history of incompletely treated tuberculosis based on medical history or medical report.
- History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at Screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
- History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization.
- History of a helminth parasitic infection within 6 months prior to the date of informed consent that has not been treated with or has failed to respond to standard of care therapy.
- History of anaphylaxis or severe allergic reaction following any biologic therapy
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04674826
Start Date
February 8 2021
End Date
December 29 2021
Last Update
February 24 2025
Active Locations (1)
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1
LEO Pharma Investigational Site
Berlin, Germany, 14050