Influenza A MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: REVTx-99
Pharmaceutical Form: Nasal drops
INN or Proposed INN: Monophosphoryl Lipid A
CAS Number: 1246298-63-4
Other descriptive name: Monophosphoryl Lipid A, PHAD®
Concentration unit:
Sponsors
Revelation Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females aged 18-55 years inclusive at the point of study screening. 2. Subject must be a non-smoker, non-tobacco user and non-nicotine product user or a former smoker/user (has not smoked, vaped or used tobacco/nicotine products in the 6 months prior to dosing). 3. Subject must have normal pulmonary function as measured by spirometry defined as 1) a forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio =0.70 and 2) FEV1 =80 % at screening and 3) peripheral oxygen saturation (SpO2) =92% on room air. 4. Subject must have a Body Mass Index (BMI) of =18.0kg/M2 and =32.0kg/M2. 5. Female subjects must be willing not to become pregnant for at least 8 weeks after last dose of study drug, not be breast feeding. 6. Female subjects must be not pregnant, and one of the following: Of non-childbearing potential (i.e. women who have had a hysterectomy bilateral salpingectomy or bilateral oophorectomy or are post-menopausal, as defined by no menses in =1 year), Or, Of childbearing potential but agrees to practice highly effective contraception from screening until 8 weeks after the date of Viral Challenge / last dose of IMP (whichever occurs last). Highly effective methods of contraception include one or more of the regimens as outlined in Section 8.5.1 of the protocol. 7. Male subjects must be surgically sterile or using a medically acceptable contraceptive regimen 8. Subjects in agreement not to use prescription or over-the-counter medications within 14 days prior to receiving study drug or placebo, through to the final follow-up visit, unless approved by the investigator and sponsor medical monitor. 9. Sero-suitability for challenge virus MNT=20. 10. Negative screen for respiratory pathogens by RT-PCR Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with self-reported of medically documented chronic pulmonary disease (e.g., asthma, COPD). 2. Subjects with self-reported or medically documented history of nasal or allergic disease (Allergic rhinitis, sinusitis, asthma) requiring regular use of medication. A history of resolved childhood asthma before the age of 12 is acceptable. 3. Subjects with self-reported or medically documented craniofacial anomalies or temporal facial muscular paralysis (e.g., Bell’s Palsy) or significant abnormality altering the anatomy of the nose or nasopharynx (including significant nasal polyps). 4. Subjects with significant self-reported or medically documented cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects). 5. Subjects with self-reported or medically documented immunosuppression, immunodeficiency, autoimmunity (with the exception of atopic dermatitis/eczema) or ongoing malignancy. 6. Subjects with a history of malignancy within 3 years prior to screening. 7. Subjects with self-reported or medically documented neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy (exception for febrile seizure), stroke, seizures). 8. Subjects with clinically significant abnormal electrocardiogram (ECG) and/or parameters, as determined by the Investigator. 9. Incidence or clinical evidence of acute respiratory illness in the 28 days prior to study drug administration. 10. Incidence of a SARS-CoV-2 infection in the past 3 months, defined by a positive test result. 11. Subjects having undergone nasal or sinus surgery in the 6 months prior to study drug administration. 12. Subject has had a new nasal piercing of any kind in the last 6 months prior to study drug administration. 13. Subjects with a history of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. 14. Subjects with any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or history of being hospitalized due to epistaxis on any previous occasion. 15. Receipt of any intranasal medication or nasal topical treatment in the 28 days prior to study drug administration, or plan to use any nasal products during the study. 16. Prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months taken from the date of study drug administration. 17. Subject in receipt of any vaccine in the 14 days prior to study confinement drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of REVTx-99 in reducing influenza virus load in the upper airways during infection. ;Secondary Objective: To assess the safety and tolerability of REVTx-99 treatment prophylactically in healthy subjects challenged with Influenza A H3N2 virus. To determine the overall effect of REVTx-99 on measurements of influenza disease severity.;Primary end point(s): Area under the curve (AUC) of viral load by RT-qPCR from NP swabs ;Timepoint(s) of evaluation of this end point: From Day 1 (pre-virus challenge) to Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The safety endpoints of this study are as follows: 1.Incidence of treatment-emergent AEs (TEAE), severity, seriousness, and causality 2.Absolute values and change from baseline in routine clinical and laboratory parameters 3.Treatment- related physical examination findings 4.Absolute values and change from baseline in peak flow The secondary endpoints of this study are as follows: 1.The Area Under the Curve (AUC) of Total Symptom Score 2.Duration of symptoms 3.Peak Symptoms Score 4.Peak Virus load 5.Duration of influenza virus presence 6.Incidence of Mild to Moderate Influenza disease (MMID) 7.Incidence of seroconversion ;Timepoint(s) of evaluation of this end point: The safety endpoints: Starting post-dose (Cohort 1)/post-first dose (Cohort 2) to Day 21. The secondary endpoints: The Area Under the Curve (AUC) of Total Symptom Score, Duration of symptoms, Peak Symptoms Score, Peak Virus load, Duration of influenza virus presence, Incidence of Mild to Moderate Influenza disease (MMID): From Day 1 (pre-virus challenge) to Day 10. Incidence of seroconversion: Assess the effect of REVTx-99 on seroconversion measured by the ratio of Influenza A (H3N2 – challenge strain) virus antibodies at Day 10 and Day 21 versus Day 1 (pre-virus challenge), compared to placebo. | — |
Countries
Belgium
Contacts
Public ContactRevelation Biosciences Information
Revelation Biosciences
Outcome results
None listed