Phase
Condition
Pneumonia
Treatment
FLAMOD
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 effectivecontraception, males willing to practice contraception or having a partner usingcontraception (if having heterosexual intercourse)
non-smoker subject (included e-cigarette smoking) since at least 3 months and ableto not smoke during the whole trial
maximum alcohol consumption defined as: i. no more than ten standard glasses perweek; ii. no more than two standard glasses per day; iii. having alcohol-free dayduring the week
volunteer should be healthy after a clinical examination
affiliation with a social security scheme or beneficiary of such a scheme
Exclusion
Exclusion Criteria:
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., thosewith asplenism, acquired immune deficiency syndrome, or immunoglobulindeficiencies), patients with haematological diseases or solid cancers, solid organor stem-cell transplant recipients, as well as patients with other conditionsrequiring immunosuppression (e.g., rheumatic and autoimmune diseases, inflammatorybowel disease, or multiple sclerosis)
administration, less than 5 x t1/2 before FLAMOD's administration, of any medicationor treatment that may alter the FLAMOD immune responses, such as but not limited to:
systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for morethan 7 consecutive days or for 10 or more days in total, within 1 month priorto the visit 1. Inhaled and intranasal steroid preparations whatever the dosewithin 1 month prior to the visit 1.
cytotoxic, antineoplastic, immunosuppressant drugs including: calcineurininhibitors immunoglobulin, mTOR inhibitors, JAK inhibitors, unspecificimmunosuppressors, TNF-alpha inhibitors, immunosuppressive monoclonalantibodies [e.g., rituximab or infliximab], any anti-cytokine biologicaltreatment (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, orheart rate less than 50 or over 100 bpm)
abnormal ECG that is, in the investigator's opinion, clinically significantincluding: heart rate <50 BPM, PR interval > 220 ms, QRS interval ≥ 120 ms, QTcinterval > 450 ms (QT corrected using Bazett's method), second or third-degreeatrioventricular block, any rhythm, other than sinus rhythm, that is interpreted bythe investigator to be clinically significant
subjects whose baseline laboratory values are outside of the normal range, as shownin Appendix 3 - Normal laboratory values unless the abnormality is considered not tobe 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 vitalcapacity (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 theinvestigator, would compromise the safety or rights of a volunteer participating inthe 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)
Study Design
Connect with a study center
Centre hospitalier régional universitaire de de Tours
Tours, 37044
FranceActive - Recruiting
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