A study in healthy young adults to compare how safe, well-tolerated, and effective INNA-051 is when given using either a single-use or a multi-use nasal spray system, and to understand participants’ experiences with each.

Exclusion Criteria16

• History or findings on physical examination of any significant disease or disorder (e.g. cardiovascular, nasal, pulmonary, gastrointestinal, liver, renal, neurological, immunological, musculoskeletal, endocrine, metabolic, malignant psychiatric, major physical impairment) 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 participant’s ability to participate in the study.
• History of or evidence at Screening or Day -1 of tachyarrhythmias, heart block, or ischemic changes, which are clinically significant or pose a risk to the participant or the study in the Investigator’s opinion.
• Clinically significant abnormal laboratory assessments at Screening or Day -1.
• Are pregnant or breastfeeding based on test result during Screening period.
• Chronic tobacco use (5 pack-years or more*), chronic cannabis smoking, and/or chronic vaping (defined as use 3 or more days/week) within 60 days prior to Screening, and/or positive urine cotinine and/or exhaled carbon monoxide test at admission. *Pack-years is defined as the number of cigarette packs smoked per day (20 cigarettes per pack) multiplied by the number of years smoking that amount.
• Nasal conditions likely to affect the outcome of the study, e.g. nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds.
• Medical condition, injury, or deformity of the hands that prevents use of the administration system.
• Active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis, within the 30 days prior to Screening, or between Screening and Day -1.
• Upper respiratory tract infection or nasal symptoms within the 3 weeks prior to Screening, or between Screening and Day -1.
• Positive test result for human immunodeficiency virus, active hepatitis B virus, or hepatitis C virus.
• Administration of any intranasal and/or inhaled product, including vaccines, antihistamines and decongestants within the 7 days prior to dosing.
• Use of acute 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. Participants on chronic 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 and does not pose a risk to the participant in the Investigator’s opinion.
• Positive drug test or alcohol breath test at Screening or Day -1, unless assessed as due to an allowed concomitant medication, and/or significant history of alcohol or drug abuse within the 12 months prior to Screening.
• Received an investigational product within 30 days or 5 half-lives (whichever is longer) prior to baseline, or concurrent participation in other clinical trials.
• History of drug or other allergy that, in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in this study.
• Inability to communicate properly, to understand the requirements of the study, or to stay in the trial unit for the required period.