PneumoniaPhase 1NEBUFLAGNCT06681402
Phase I Single-blind Clinical Trial to Evaluate the Safety and Local Immune Activation of a Toll-like Receptor 5 Agonist (FLAMOD) Administered by Aerosol
A Phase 1 study testing FLAMOD in people with Pneumonia, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
This is a single-blind, randomized, placebo-controlled, dose-escalation phase I monocentric trial assessing a single administration of FLAMOD by aerosol in healthy subjects. The recruitment is performed by the Clinical Investigation Center of Tours. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- FLAMOD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2025to 17 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- provision of signed and dated informed consent form
- stated willingness to comply with all trial procedures, clinic visits, blood draws, and availability for the duration of the trial
- human subjects who are between 18 and 65 years of age
- weight of at least 50 kg and body mass index (BMI) within the range of 18 - 30 kg/m²
- females of non-childbearing potential or of childbearing potential with effective contraception, males willing to practice contraception or having a partner using contraception (if having heterosexual intercourse)
- non-smoker subject (included e-cigarette smoking) since at least 3 months and able to not smoke during the whole trial
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- maximum alcohol consumption defined as: i. no more than ten standard glasses per week; ii. no more than two standard glasses per day; iii. having alcohol-free day during the week
- volunteer should be healthy after a clinical examination
- affiliation with a social security scheme or beneficiary of such a scheme
Who cannot join
- febrile and/or suspected infection
- history of chronic pulmonary disease
- history of acute pulmonary disease in the past 6 months
- immunocompromised individuals, which includes immunodeficient patients (e.g., those with asplenism, acquired immune deficiency syndrome, or immunoglobulin deficiencies), patients with haematological diseases or solid cancers, solid organ or stem-cell transplant recipients, as well as patients with other conditions requiring immunosuppression (e.g., rheumatic and autoimmune diseases, inflammatory bowel disease, or multiple sclerosis)
- administration, less than 5 x t1/2 before FLAMOD's administration, of any medication or treatment that may alter the FLAMOD immune responses, such as but not limited to:
- systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for more than 7 consecutive days or for 10 or more days in total, within 1 month prior to the visit 1. Inhaled and intranasal steroid preparations whatever the dose within 1 month prior to the visit 1.
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- cytotoxic, antineoplastic, immunosuppressant drugs including: calcineurin inhibitors immunoglobulin, mTOR inhibitors, JAK inhibitors, unspecific immunosuppressors, TNF-alpha inhibitors, immunosuppressive monoclonal antibodies [e.g., rituximab or infliximab], any anti-cytokine biological treatment (e.g. TNF-alpha inhibitors, anti-IL6 agents, anti-IL1 agents); within 12 months prior to the visit 1.
- concurrent immunostimulant drugs or biologic agents including: growth factors, cytokines, interleukins, interferons; within 12 months prior to the visit 1.
- administration of vaccine within 1 month prior to visit 1.
- administration of anticoagulant treatments: warfarin (coumadin), fondaparinux, heparin (unfractionated Heparin), low molecular weight heparin (enoxaparin, dalteparin), direct oral anticoagulants (rivaroxaban, apixaban, edoxaban, dabigatran); within 1 week prior to the visit 1
- pregnant or lactating woman
- inability to tolerate a nebulization test with saline
- clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 150 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm)
- abnormal ECG that is, in the investigator's opinion, clinically significant including: heart rate <50 BPM, PR interval > 220 ms, QRS interval ≥ 120 ms, QTc interval > 450 ms (QT corrected using Bazett's method), second or third-degree atrioventricular block, any rhythm, other than sinus rhythm, that is interpreted by the investigator to be clinically significant
- subjects whose baseline laboratory values are outside of the normal range, as shown in Appendix 3 - Normal laboratory values unless the abnormality is considered not to be of clinical relevance by the investigator
- positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
- positive urine nicotine test
- positive urine multi-drug test
- abnormal chest x-ray
- clinically significant abnormality of baseline spirometry tests: forced vital capacity (FVC) <90% predicted; forced expiratory volume in one second (FEV1) <80% predicted; FEV1/FVC ratio <80% or diffusion capacity of the lung for carbon monoxide (DLCO) <70% predicted
- history or presence of drug or chronic alcohol abuse
- history of severe psychiatric disorders that may affect participation in the trial
- significant concurrent illness and any other condition that, in the opinion of the investigator, would compromise the safety or rights of a volunteer participating in the trial or render the subject unable to comply with the protocol
- person subject to a legal protection measure
- subject in the exclusion period of a previous study
- known allergy or intolerance to study drug (including any of its constituents, e.g. FLAMOD and polysorbate 80)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier régional universitaire de de Tours
Tours, 37044
About this study
This is a single-blind, randomized, placebo-controlled, dose-escalation phase I monocentric trial assessing a single administration of FLAMOD by aerosol in healthy subjects. The recruitment is performed by the Clinical Investigation Center of Tours. This trial is divided in two stages:
- the "start-up phase" consisting of a dose escalation to ensure the safety of FLAMOD while allowing sufficient information on the molecule activity to be accumulated
- the dose-finding phase estimating several dose-activity models and then selecting the one that best fits the data to then propose the dose for the next cohort of participants.
- Conditions
- Pneumonia
- Being tested
- FLAMOD, Placebo
- Keywords
- Immunotherapy, Inhalation, Antibiotic resistance, Flagellin, Pneumonia
- Medical subject headings
- Pneumonia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLAMODDrug
FLAMOD (GMP-grade flagellin) inhalation
PlaceboDrug
Placebo inhalation
| Study group | Role | What they receive |
|---|---|---|
| FLAMOD | Experimental | Not described Receives: Drug: FLAMOD |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single administration dose of FLAMOD
The safety of FLAMOD is assessed via the proportion of Serious Adverse Events, critical safety events, serious adverse reactions, and cytokine release syndrome grade 2 and above.
The tolerability of FLAMOD is assessed via the proportion of treated participants who experience laboratory abnormalities and/or Adverse Events as defined by Common Terminology Criteria for Adverse Events v5.0.
Measured: From enrollment to the end of follow-up (at 2 weeks +/- 4 days post administration)
Secondary outcomes (4)
FLAMOD immune activating dose (IAD)
Biological activity of FLAMOD is assessed by systemic biomarker surrogates. The lowest dose that reaches immune activation in a maximum number of healthy volunteers is considered as IAD.
Measured: From enrollment to visit 2 (24 hours + 3-day window post administration)
Local immune-enhancing effect of FLAMOD on nasal epithelial lining fluid
Multiomic analyses (proteomic and transcriptomic analyses) will be performed subsequently on nasal epithelial lining fluid collected by nasosorption for proteomic study with a special focus on IL-6, IL-8, CCL20 but not only.
Measured: From enrollment to visit 2 (24 hours + 3-day window post administration)
Local immune-enhancing effect of FLAMOD on nasal epithelial cells
Multiomic analyses (proteomic and transcriptomic analyses) will be performed subsequently on nasal epithelial cells collected by nasal curettage for transcriptomic study to identify differentially expressed genes and pathways.
Measured: From enrollment to visit 2 (24 hours + 3-day window post administration)
Systemic immune-enhancing effect of FLAMOD
Multiomic analyses (proteomic and transcriptomic analyses) will be performed subsequently on blood collected for proteomic study to complete the characterization of the immune response, in addition to IL-6, CRP, PCT and neutrophils that will be available in blood in a short turnaround time.
Measured: From enrollment to visit 2 (24 hours + 3-day window post administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start14 Apr 2025
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Antoine Guillon, MD, Principal investigator, Centre Hospitalier Régional Universitaire de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681402
- Sponsor's protocol ID
- C20-48
- Other IDs
- 2024-515933-14-00
- Acronym
- NEBUFLAG
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and/or samples obtained through this study may be provided to perform new researches on immunology and infectiology fields. Data or samples shared will be coded. The request will be assessed by the sponsor with scientific advice and may require agreement (e.g. a data/material transfer agreement) and accomplishment of regulatory process (e.g. competent authority authorisation) before sharing of data and/or samples with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Single-blind Clinical Trial to Evaluate the Safety and Local Immune Activation of a Toll-like Receptor 5 Agonist (FLAMOD) Administered by Aerosol
- ClinicalTrials.gov ID
- NCT06681402
- Acronym / sponsor ID
- NEBUFLAG / C20-48
- Conditions
- Pneumonia
- Keywords
- Immunotherapy, Inhalation, Antibiotic resistance, Flagellin, Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- European Union
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 8 Nov 2024 (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.
This is a single-blind, randomized, placebo-controlled, dose-escalation phase I monocentric trial assessing a single administration of FLAMOD by aerosol in healthy subjects. The recruitment is performed by the Clinical Investigation Center of Tours. This trial is divided in two stages:
- the "start-up phase" consisting of a dose escalation to ensure the safety of FLAMOD while allowing sufficient information on the molecule activity to be accumulated
- the dose-finding phase estimating several dose-activity models and then selecting the one that best fits the data to then propose the dose for the next cohort of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLAMOD | Experimental | Drug: FLAMOD |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- provision of signed and dated informed consent form
- stated willingness to comply with all trial procedures, clinic visits, blood draws, and availability for the duration of the trial
- human subjects who are between 18 and 65 years of age
- weight of at least 50 kg and body mass index (BMI) within the range of 18 - 30 kg/m²
- females of non-childbearing potential or of childbearing potential with effective contraception, males willing to practice contraception or having a partner using contraception (if having heterosexual intercourse)
Key exclusion criteria (26 listed)
- febrile and/or suspected infection
- history of chronic pulmonary disease
- history of acute pulmonary disease in the past 6 months
- immunocompromised individuals, which includes immunodeficient patients (e.g., those with asplenism, acquired immune deficiency syndrome, or immunoglobulin deficiencies), patients with haematological diseases or solid cancers, solid organ or stem-cell transplant recipients, as well as patients with other conditions requiring immunosuppression (e.g., rheumatic and autoimmune diseases, inflammatory bowel disease, or multiple sclerosis)
- administration, less than 5 x t1/2 before FLAMOD's administration, of any medication or treatment that may alter the FLAMOD immune responses, such as but not limited to:
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 |
|---|---|---|
| FLAMODFLAMOD (GMP-grade flagellin) inhalation | Drug | FLAMOD |
| PlaceboPlacebo inhalation | Drug | Placebo |
Primary outcome
Safety and tolerability of a single administration dose of FLAMOD
Time frame: From enrollment to the end of follow-up (at 2 weeks +/- 4 days post administration)
The safety of FLAMOD is assessed via the proportion of Serious Adverse Events, critical safety events, serious adverse reactions, and cytokine release syndrome grade 2 and above. The tolerability of FLAMOD is assessed via the proportion of treated participants who experience laboratory abnormalities and/or Adverse Events as defined by Common Terminology Criteria for Adverse Events v5.0.
4 secondary outcomes
FLAMOD immune activating dose (IAD)
Time frame: From enrollment to visit 2 (24 hours + 3-day window post administration)
Local immune-enhancing effect of FLAMOD on nasal epithelial lining fluid
Time frame: From enrollment to visit 2 (24 hours + 3-day window post administration)
Local immune-enhancing effect of FLAMOD on nasal epithelial cells
Time frame: From enrollment to visit 2 (24 hours + 3-day window post administration)
Systemic immune-enhancing effect of FLAMOD
Time frame: From enrollment to visit 2 (24 hours + 3-day window post administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. Data and/or samples obtained through this study may be provided to perform new researches on immunology and infectiology fields. Data or samples shared will be coded. The request will be assessed by the sponsor with scientific advice and may require agreement (e.g. a data/material transfer agreement) and accomplishment of regulatory process (e.g. competent authority authorisation) before sharing of data and/or samples with the requesting party.
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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. This study is not recruiting at the moment.
Antoine Guillon, MD principal investigator
Centre Hospitalier Régional Universitaire de Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FLAMOD in people with Pneumonia, run by Institut National de la Santé Et de la Recherche Médicale, France 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 9 inclusion and 26 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: finished, as of the sponsor's last update on 21 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of a single administration dose of FLAMOD (time frame: From enrollment to the end of follow-up (at 2 weeks +/- 4 days post administration)). 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 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.