None listed
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of REVx-99, as well as the Pharmacokinetics (PK- how your body uses the study drug) and pharmacodynamics (PD - how the study drug carries out its actions on the body). We are doing this study in healthy men and women to find out: - Does the drug have any side-effects and is it well tolerated when given as a single dose? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? This study will compare REVTx-99 with placebo. A placebo has no active drug in it. One group of participants will receive REVTx-99 and another group will receive the placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. We will be testing a single dose of the study drug in up to 40 healthy volunteers who will be divided into 5 cohorts of 8 people each and testing multiple doses in a single cohort of 8 people. Each single dose cohort is planned to receive an increasing dose of REVTx-99.
Interventions
The study consists of 5 single dose cohorts and 1 multiple dose cohort which will be studied sequentially. Participants in each single dose cohort will receive a single dose of either placebo or 5 mcg, 15 mcg, 30 mcg, 50 mcg or 100 mcg of REVTx-99 intranasally. Participants in the multiple dose cohort will receive 100 mcg of REVTx-99 intranasally every day for 5 days. Study drug will be administered by a registered nurse.
Sponsors
Linear Clinical Research Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant must be a healthy, adult volunteers, 18-50 years of age, inclusive at Screening. 2. Participant must test negative for influenza; and SARS-CoV-2 by RT-PCR at Screening and should be performed no more than 1 week prior to dosing. 3. Participant must be willing and able to provide written informed consent. 4. Participant must be a nonsmoker, nontobacco 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). 5. Participant must have a Body Mass Index (BMI) more than or equal to 18.0 kg/M2 and less than or equal to 30.0 kg/M2 6. Female participants must be of non-childbearing potential or using a medically acceptable contraceptive regimen from Screening until 30 days post-dose. 7. Male participants must be surgically sterile or using a medically acceptable contraceptive regimen, from screening until 90 days post-dose. 8. Participant must be willing and able to comply with the study schedule, restrictions, and requirements.
Exclusion criteria
1. Participants with a concomitant disease, disability, or condition which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the participants in this study, including, but not limited to alcohol dependency or abuse, drug dependency or abuse, or previously diagnosed psychiatric disease. 2. Participants who have a history of Bell’s palsy. 3. Participants who give a verbal history of risk factors for SARS-CoV-2 and other common viral respiratory infections including, but not limited to, pre-existing pulmonary disease such as asthma, reactive airway disease, chronic obstructive pulmonary disease, pulmonary hypertension, and emphysema. 4. Participants who give a verbal history of being immunocompromised due to disease or medication (e.g. cancer immunosuppressive therapy), hypertension, coronary artery disease with history of stent or graft, heart failure NYHA class 2 or greater, or diabetes. 5. Participants who have used any prescription medications within 14 days or over-the- counter medications within 7 days before study drug dosing, with the exception of contraceptives for female participants and occasional paracetamol use (at the discretion of the Investigator). 6. Participants who have used vitamins, dietary or herbal supplement, or nutritional supplement within 7 days before study drug dosing. 7. Participant has a history of chronic sinusitis requiring regular use of nasal spray. 8. Participant has had recent nasal surgery or invasive nasal or dental procedure in the preceding 28 days of Day -1. 9. Participant has had active allergic rhinitis within 14 days prior to administration of first dose of Investigational Product. 10. Participant has had administration of systemic antibiotics or antivirals within 7 days prior to Screening (excluding topical/external use of antibiotics). 11. Participant has had major surgery within 30 days of Day -1. 12. Pregnant or breast-feeding women. 13. Participant has received of any immunoglobulins and/or blood products within 3 months of study Screening. 14. Participant has had acute respiratory illness within 30 days prior to administration of first dose of Investigational Product. 15. Participant has used or been administered any intranasal medication or nasal topical treatment within 30 days of Day -1, or plan to use any nasal products during the study. 16. Participant is using systemic corticosteroids including low-dose oral prednisone and any systemic immunomodulatory therapy. 17. Participant has received treatment with any investigational product in any clinical study within 30 days of Day -1 or five half-lives, whichever is longer. 18. Participant has received a vaccination within 30 days of dosing 19. Participant is unwilling or unable to comply with the study protocol requirements.
Outcome results
None listed