None listed
Conditions
Brief summary
INNA051 is being developed as a prophylactic against SARS-CoV-2 (coronavirus). This is the first in human trial of INNA051 and will test increasing doses of study drug for safety and tolerability, and to measure how the immune system responds.
Interventions
Part A: Single dose intra nasal INNA051. Cohort 1 will be 20mg, subsequent doses to be determined during the study based on safety data.
Part B and Part C: Intra nasal INNA051 administered on Day 1, Day 4, Day 7, and Day 10, or Day 1, Day 8, Day 15, and Day 22. Doses to be determined based on Part A data
Each participant will be included in one cohort only.
All doses will be administered by site staff.
Sponsors
Ena Respiratory Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults 18 to less than 65 years of age (Part A and Part B), or 65 to 85 years of age inclusive (Part C) at the time of providing written informed consent. 2. Agree to the contraception requirements specified in protocol 3. Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 4. Body weight at least 50 kg and body mass index (BMI) within the range 18 – 34.9 kg/m2 (inclusive). 5. Participants with screening forced expiratory volume in one second (FEV1) at least 80% of the predicted value. 6. Willing and able to comply with the study requirements.
Exclusion criteria
1. History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject’s ability to participate in the study. 2. Clinically significant laboratory assessments at Screening or Day -1 3. Pregnant or breast feeding 4. Chronic tobacco use or vaping within 60 days prior to screening, and/or positive urine cotinine and/or exhaled carbon monoxide test at check-in. 5. Current diagnosis of asthma. 6. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds. 7. History within 30 days prior to informed consent of active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis 8. Participants with nasal symptoms of upper respiratory tract infection within the 3 weeks prior to screening or baseline. . 9. Positive human immunodeficiency virus (HIV), active hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test. 10. Administration of any intranasal product within the 30 days prior to dosing. 11. Use of prescription or non-prescription drugs within 7 days prior to dosing, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety. NOTE: Part C participants on medications may be included if the medication has been stable for at least 6 weeks prior to screening and is expected to remain stable during the study period. 12. Positive drug test or alcohol breath test at screening or Day -1, and/or significant history of alcohol or drug abuse as defined in the protocol. 13. Received an investigational product within 30 days or 5 half-lives (whichever is longer) prior to baseline, or concurrent participation in other clinical trials. COVID-19 vaccines will not be exclusionary unless administered intranasally within the 30 days prior to dosing. 14. History of drug or other allergy that, in the opinion of the Investigator or Ena Respiratory’s Medical Monitor, contraindicates participation in this study. 15. Inability to communicate properly and/or understand the requirements of the study. 16. Institutionalised individuals.
Outcome results
None listed