None listed
Conditions
Brief summary
INNA051 is being developed as a prophylactic against respiratory viruses, for example influenza (the flu), SARS-CoV-2 (coronavirus), and respiratory syncitial virus (RSV). This study will test increasing doses of a dry powder formulation of study drug for safety and tolerability, and to measure how the immune system responds in older adults.
Interventions
Cohort 1: Single dose intra nasal INNA051 150 micrograms administered on Day 1.
Cohorts 2, 3, 4, and 5: Intra nasal INNA051 administered on Day 1, Day 8, and Day 15. Doses to be confirmed based on Cohort 1 data
Cohort 6: Single dose intra nasal INNA051 300 micrograms administered on Day 1.
Cohort 7: Single dose intra nasal INNA051 administered on Day 1. Dose to be confirmed based on previous cohort data
Each cohort has 8 participants; 6 will receive INNA-051.
Each participant will be included
Cohort 1: Single dose intra nasal INNA051 150 micrograms administered on Day 1. Cohorts 2, 3, 4, and 5: Intra nasal INNA051 administered on Day 1, Day 8, and Day 15. Doses to be confirmed based on Cohort 1 data Cohort 6: Single dose intra nasal INNA051 300 micrograms administered on Day 1. Cohort 7: Single dose intra nasal INNA051 administered on Day 1. Dose to be confirmed based on previous cohort data Each cohort has 8 participants; 6 will receive INNA-051. 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 No maximum
Healthy volunteers
Yes
Inclusion criteria
- Males and females 60 years of age or older (cohorts 1 - 5) and 18 to 45 years (cohorts 6 & 7) Without clinically defined unstable disease, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Body weight 50 kg or above and body mass index (BMI) 18 to 34.9 kg/m2 (inclusive). - Forced expiratory volume in one second (FEV1) at least 80% of the predicted value at Screening.
Exclusion criteria
- Any significant disease or disorder which may put the subject at risk because of participation in the study, influence the results of the study or the participant’s ability to participate in the study. - History or evidence of tachyarrhythmias, heart block, or ischemic changes. - Clinically significant abnormal laboratory assessments - Chronic tobacco use, chronic cannabis smoking, or chronic vaping. - Nasal conditions likely to affect the outcome of the study, for example nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds. - Active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis - Upper respiratory tract infection or nasal symptoms
Outcome results
None listed