Phase
Condition
N/ATreatment
N-IP-00001 inhalation solution
0.9% NaCl isotonic saline solution
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 orsub-investigator (who is a qualified physician)through physical examination, vitalsigns and laboratory parameters.
No current acute or chronic respiratory conditions.
FEV1 ≥ 80% predicted.
Ability to achieve reproducible FEV1 spirometry, as determined by 3 acceptablemaneuvres within no more than 5 attempted maneuvres. The best two values should bewithin 5% or 150mL of each other, whichever is greater.
Ability to comply with study medication use, study visits, and study procedures asjudged by the investigator.
Able to understand and sign an informed consent.
Non-smoker and has not smoked for at least 6 months.
Exclusion
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 ofalcohol per week for males and >14 units of alcohol per week for females. Where 1unit = 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 screeningvisit or positive alcohol breath test at check-in.
Not able and willing to refrain from alcohol from 24 hours before the first dosethrough study confinement
Unwilling to abstain from fermented foods (kimchi, yoghurt, kefir, kombucha,sauerkraut) and strenuous exercise for 24 hours prior to dosing. Unwilling toabstain from consuming caffeine and/or xanthene products (e.g., coffee, tea,chocolate, and caffeine-containing sodas, colas) during confinement at the clinicalunit'.
Participants who have received any investigational drug in a clinical research studywithin 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.
Study Design
Connect with a study center
Linear Clinical Research Ltd
Perth, Western Australia 6009
AustraliaSite Not Available
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