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RecruitingNCT05160337Updated Jun 24, 2026

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

An interventional study of Biomarker based IVD tests in Healthy, sponsored by Firalis SA. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Firalis SA · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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

Read the detailed description

Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests measure in blood and other peripheral body fluids; long non-coding RNAs (lncRNAs), small non-coding RNAs (sncRNAs), messenger RNAs (mRNAs), circulating proteins, lipids and metabolites. In addition, since 2020, Firalis is producing the salivary test EasyCOV for detection of Covid-19 positivity in both symptomatic and asymptomatic subjects. Firalis group is the sponsor of a pipeline of various clinical studies conducted in diverse National and European clinical sites of excellence, enrolling patients affected by the targeted diseases studied such as acute myocardial injury, Alzheimer disease for the proof of performance phase of the biomarkers and IVD test candidates. The present specific study aims to collect biological samples to complete the analytical validation of its diverse IVD tools namely the evaluation of the stability of the biomarkers and the effect of age, gender, nutrition and inter-period on the expression level of the studied biomarkers.

02

Conditions studied

  • Healthy

Keywords

  • biomarkers
  • chronobiology
  • healthy volounteers
  • diagnostic biomarkers
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Healthy Volunteers

    Healthy Volunteers will be recruited into the study

    Diagnostic Test: Biomarker based IVD tests

Interventions

  • Diagnostic testBiomarker based IVD tests

    Biomarker based IVD tests

05

What researchers measure

Primary outcomes

  1. lncRNA Biomarker expression before breakfast intake

    lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples

    Time frame: T0- Baseline in the morning before breakfast at fasting conditions

  2. lncRNA Biomarker expression after breakfast intake

    lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples

    Time frame: T1- 1 hour after breakfast

Secondary outcomes

  1. sncRNA Biomarker expression before breakfast intake

    sncRNA cycle threshold measured in blood plasma

    Time frame: T0- Baseline in the morning before breakfast at fasting conditions

  2. sncRNA Biomarker expression after breakfast intake

    sncRNA cycle threshold measured in blood plasma

    Time frame: T1- 1 hour after breakfast

  3. mRNAs Biomarker expression before breakfast intake

    mRNAs cycle threshold measured in blood plasma

    Time frame: T0- Baseline in the morning before breakfast at fasting conditions

  4. mRNAs Biomarker expression after breakfast intake

    mRNAs cycle threshold measured in blood plasma

    Time frame: T1- 1 hour after breakfast

  5. Soluble proteins Biomarker expression before breakfast intake

    Soluble proteins expression in ng/mL measured in blood plasma

    Time frame: T0- Baseline in the morning before breakfast at fasting conditions

  6. Soluble proteins Biomarker expression after breakfast intake

    Soluble proteins expression in ng/mL measured in blood plasma

    Time frame: T1- 1 hour after breakfast

06

Study locations

1 of 1 sites recruiting
  • Firalis Clinical Investigation Center
    Huningue, 68330, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05160337
Lead sponsor
Firalis SA
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Jun 18, 2025
Primary completion
Aug 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jun 24, 2026

Study contacts

Federica ZILLI, PhD
Contact
clinical@firalis.com
0389911320
Hueseyin Firat, MD, PhD, HDR
Contact
clinical@firalis.com
0389911320
Pierre Rohrlich, MD,Phd
principal investigator · Firalis SA
Hueseyin Firat, MD, PhD, HDR
study director · Firalis SA
Stephanie Boutillier, PhD
study chair · Firalis SA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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