HealthyNCT05160337
Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers
A study testing Biomarker based IVD tests in people with Healthy, run by Firalis SA at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Biomarker based IVD tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Firalis Clinical Investigation Center
Huningue, 68330
Federica Zilli, PhD, 0389911320, federica.zilli@firalis.com
About this study
Official title: Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis
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.
- Conditions
- Healthy
- Being tested
- Biomarker based IVD tests
- Keywords
- biomarkers, chronobiology, healthy volounteers, diagnostic biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker based IVD testsDiagnostic test
Biomarker based IVD tests
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Healthy Volunteers will be recruited into the study Receives: Diagnostic Test: Biomarker based IVD tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
lncRNA Biomarker expression before breakfast intake
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
Measured: T0- Baseline in the morning before breakfast at fasting conditions
lncRNA Biomarker expression after breakfast intake
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
Measured: T1- 1 hour after breakfast
Secondary outcomes (6)
sncRNA Biomarker expression before breakfast intake
sncRNA cycle threshold measured in blood plasma
Measured: T0- Baseline in the morning before breakfast at fasting conditions
sncRNA Biomarker expression after breakfast intake
sncRNA cycle threshold measured in blood plasma
Measured: T1- 1 hour after breakfast
mRNAs Biomarker expression before breakfast intake
mRNAs cycle threshold measured in blood plasma
Measured: T0- Baseline in the morning before breakfast at fasting conditions
mRNAs Biomarker expression after breakfast intake
mRNAs cycle threshold measured in blood plasma
Measured: T1- 1 hour after breakfast
Soluble proteins Biomarker expression before breakfast intake
Soluble proteins expression in ng/mL measured in blood plasma
Measured: T0- Baseline in the morning before breakfast at fasting conditions
Soluble proteins Biomarker expression after breakfast intake
Soluble proteins expression in ng/mL measured in blood plasma
Measured: T1- 1 hour after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start18 Jun 2025
- Primary completionAug 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firalis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Rohrlich, MD,Phd, Principal investigator, Firalis SAHueseyin Firat, MD, PhD, HDR, Study director, Firalis SAStephanie Boutillier, PhD, Study chair, Firalis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160337
- Sponsor's protocol ID
- 2021-A00405-36
- Status last verified
- Jun 2026
- First submitted
- 8 Nov 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis
- ClinicalTrials.gov ID
- NCT05160337
- Acronym / sponsor ID
- 2021-A00405-36
- Conditions
- Healthy
- Keywords
- biomarkers, chronobiology, healthy volounteers, diagnostic biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Firalis SAIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Diagnostic Test: Biomarker based IVD testsHealthy Volunteers will be recruited into the study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker based IVD testsBiomarker based IVD tests | Diagnostic test | Healthy Volunteers |
Primary outcome
lncRNA Biomarker expression before breakfast intake
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
lncRNA Biomarker expression after breakfast intake
Time frame: T1- 1 hour after breakfast
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
6 secondary outcomes
sncRNA Biomarker expression before breakfast intake
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
sncRNA Biomarker expression after breakfast intake
Time frame: T1- 1 hour after breakfast
mRNAs Biomarker expression before breakfast intake
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
mRNAs Biomarker expression after breakfast intake
Time frame: T1- 1 hour after breakfast
Soluble proteins Biomarker expression before breakfast intake
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
Soluble proteins Biomarker expression after breakfast intake
Time frame: T1- 1 hour after breakfast
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Rohrlich, MD,Phd principal investigator
Firalis SA
Hueseyin Firat, MD, PhD, HDR study director
Firalis SA
Stephanie Boutillier, PhD study chair
Firalis SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker based IVD tests in people with Healthy, run by Firalis SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica ZILLI, PhD (0389911320, clinical@firalis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lncRNA Biomarker expression before breakfast intake (time frame: T0- Baseline in the morning before breakfast at fasting conditions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.