RecruitingNot ApplicableNCT05160337

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis

Sponsor

Firalis SA

Enrollment

60 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

Participants who sign the informed consent forms for sample collection and data collection both anonymized and reported in CRF.
Able to comply with all study procedures.
Healthy Volunteers having no apparent disease.
Adults, both genders, aged 18-85 years.
Participants with no apparent motor or mental health abnormality.
Participants having no major disabling mental or physical disability that would require hospitalization.
Body weight above 50 kg if male, above 40 kg if female.

Exclusion Criteria22

Any subject who did not sign the Informed Consent form.
Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development.
Any subject in the exclusion period of a previous study according to applicable regulations.
Any subject who cannot be contacted in case of emergency.
Any subject who is the Investigator or any sub-investigator, research assistant, study coordinator, or other staff thereof, directly involved in the conduct of the protocol.
Any subject with a disease that, in the judgement of the investigator, would interfere with the conduct of study or harm the safety of volunteer.
Subjects with disabling disease or abnormal health status are excluded.
Subjects aged below 18 years and older than 85 years are excluded.
Pregnant, parturient and nursing women are excluded.
Subjects deprived of their liberty by a judicial or administrative decision, protected adults and vulnerable persons are excluded.
Subjects who are under legal protection or who are unable to express their consent are not included.
Any subject who reports in the questionnaire of the screening period having one of the following diseases is excluded:
Any psychiatric or neurodegenerative disease or neurologic disorder.
Hypertension.
Any cardiovascular disease.
Any chronic inflammatory disease such as rheumatoid arthritis.
Any cancer.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
Any subject who did a blood donation, any volume, within 2 months before inclusion.
Any subject who reports in the questionnaire of the screening period having medication(s) for one or more of the above diseases is excluded.
Drug or alcohol abuse or smoking more than 10 cigarettes or equivalent.
Subjects with no apparent disease and symptoms, but with unknown Covid-19 positivity are not excluded.