Bio samples and bio markers for development of the biosensor toolkit within the REMEDIA project - 21-13 REMEDIA

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM0 sites11 target enrollmentOctober 20, 2021

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy volunteers
Sponsor: Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Enrollment: 11
Status: Enrolling By Invitation
Last Updated: last year

No summary available.

Registry

who.int

Start Date

October 20, 2021

End Date

January 14, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM

•Able and willing to give written informed consent
•\- Study population: Healthy male and female subjects, aged 18 to 50 years (inclusive). Female subjects must not be pregnant or nursing. Women of child bearing potential must use a highly effective contraception method during the study
•\- Subjects must be able to produce adequate sputum (\= 2× 105 total non\-squamous cells)
•\- Body mass index between 18 and 32 kg/m2 (inclusively)
•\- Subject must be non\-smoker with a history of less than 1 pack year and not having smoked in the past years
•\- Appropriate lung function with FEV1 \= 80 % of predicted value

•\- History of allergic rhinitis in the past 5 years
•\- Acute infection or any upper respiratory tract infection four weeks prior to informed consent visit
•\- Administration of corticosteroids via any route (e.g. intranasal, inhaled, oral) 4 weeks prior to informed consent visit