Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.

Inclusion criteria

• Age ≥ 18 years and ≤ 55 years.
• Male or non-pregnant, non-lactating Female
• Normally active and in good health as determined by the investigator or sub-investigator (who is a qualified physician)through physical examination, vital signs and laboratory parameters.
• No current acute or chronic respiratory conditions.
• FEV1 ≥ 80% predicted.
• Ability to achieve reproducible FEV1 spirometry, as determined by 3 acceptable maneuvres within no more than 5 attempted maneuvres. The best two values should be within 5% or 150mL of each other, whichever is greater.
• Ability to comply with study medication use, study visits, and study procedures as judged by the investigator.
• Able to understand and sign an informed consent.
• Non-smoker and has not smoked for at least 6 months.

Exclusion criteria

• Bowel disease
• Bariatric surgery
• Evidence of biliary cirrhosis with portal hypertension
• History of any drug or alcohol abuse in the past 1 year defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females. Where 1 unit = 360ml of beer, 150ml of wine, or 45ml of spirits.
• History of lung transplant.
• History of asthma.
• History of allergic reactions to fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut)
• Antibiotic treatment within 4 weeks prior to screening
• Recent (2 weeks) upper respiratory tract infection or COVID
• Recurrent cough
• Poor venous access
• Unexplained, positive drugs of abuse or alcohol breath test results at the screening visit or positive alcohol breath test at check-in.
• Not able and willing to refrain from alcohol from 24 hours before the first dose through study confinement
• Unwilling to abstain from fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut) and strenuous exercise for 24 hours prior to dosing. Unwilling to abstain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) during confinement at the clinical unit'.
• Participants who have received any investigational drug in a clinical research study within the previous 30 days prior to screening or 5 half-lives, whichever is longer.
• Failure to satisfy the investigator of fitness to participate for any other reason.
• Currently taking any medication by the inhaled route.
• Those with commercial interest in the product or related products.