COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620001104943.aspx

Jasmine Williams

jwilliams@linear.org.au

2020-10-26

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

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.

7

Linear Clinical Research Ltd

18

50

Australia

Healthy volunteers

N/A

48

To determine the Safety and Tolerability of a single and multiple intranasal doses of REVTx-99 when administered to healthy adults as assessed by the collection of safety data; such as adverse events; clinical laboratory tests; vital signs; 12-lead ECGs and Physical Exams. The clinical laboratory tests to assess safety are as follows: Haematology: Haematocrit; Haemoglobin; Platelet count; White blood cell count and Red blood cell count. Clinical Chemistry: Serum creatinine; Uric Acid; Calcium; Total Protein; Alkaline phosphatase; Urea; Total Bilirubin; Chloride; Bicarbonate; Albumin; Sodium; Potassium; Plasma Glucose; ALT; AST and LDH.[Single Dose: Continuously from Day 1/Predose through to Day 8/Hour 168 - End-of-Study (EOS) Multiple Dose: Continuously from Day 1/Predose through to Day 12 - End-of-Study (EOS) ];To determine the pharmacodynamic (PD) effect of REVTx-99 in healthy adult volunteers as measured by nasal cytokine levels.Nasal cytokines that will be measured include: IP-10; IL-6; IFN-alpha; IFN-beta; IFN-gamma[Single Dose: Nasal mucosa cytokine levels will be measured at Day 1/Predose and postdose at Hours 10-12; Day 2/Hours 20-24; Day 3/Hours 40-50 and Day 8 (EOS)Multiple Dose: Nasal mucosa cytokine levels will be measured at Day 1-5/Predose and Day 12 (EOS)]

Phase 1

[{"arm_notes": "5 mcg; IN", "treatment_id": 1118, "treatment_name": "Revtx-99", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "15 mcg; IN", "treatment_id": 1118, "treatment_name": "Revtx-99", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "30 mcg; IN", "treatment_id": 1118, "treatment_name": "Revtx-99", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "50 mcg ; IN", "treatment_id": 1118, "treatment_name": "Revtx-99", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100 mcg ; IN", "treatment_id": 1118, "treatment_name": "Revtx-99", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100 mcg ; 5 days ; IN", "treatment_id": 1118, "treatment_name": "Revtx-99", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]