Healthy
Conditions
Keywords
safety, tolerability, inhalation
Brief summary
Randomized, double-blind, placebo-controlled, dose-escalation Phase I safety study of inhaled N-IP-00001, to determine tolerability and safety in healthy volunteers.
Interventions
DRUGN-IP-00001 inhalation solution
Multiple ascending dose (MAD) study. Over the 2 dosing days participants will receive a total of 6 inhaled doses of 5 ml of N-IP-00001 at increasing concentrations, ranging from 0.5mg/ml to 16mg/ml (total volume loaded in the nebuliser is 6 ml per dose).
Nebulized treatment consisting of 0.9% saline solution.
Sponsors
NeoTrials Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years and ≤ 55 years. 2. Male or non-pregnant, non-lactating Female 3. 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. 4. No current acute or chronic respiratory conditions. 5. FEV1 ≥ 80% predicted. 6. 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. 7. Ability to comply with study medication use, study visits, and study procedures as judged by the investigator. 8. Able to understand and sign an informed consent. 9. Non-smoker and has not smoked for at least 6 months.
Exclusion criteria
1. Bowel disease 2. Bariatric surgery 3. Evidence of biliary cirrhosis with portal hypertension 4. 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. 5. History of lung transplant. 6. History of asthma. 7. History of allergic reactions to fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut) 8. Antibiotic treatment within 4 weeks prior to screening 9. Recent (2 weeks) upper respiratory tract infection or COVID 10. Recurrent cough 11. Poor venous access 12. Unexplained, positive drugs of abuse or alcohol breath test results at the screening visit or positive alcohol breath test at check-in. 13. Not able and willing to refrain from alcohol from 24 hours before the first dose through study confinement 14. 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'. 15. 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. 16. Failure to satisfy the investigator of fitness to participate for any other reason. 17. Currently taking any medication by the inhaled route. 18. Those with commercial interest in the product or related products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Up to 2 weeks | — |
| FEV1 measured by spirometry | Up to 2 weeks | — |
| Changes in vital signs | Up to 2 weeks | Changes in blood pressure, temperature, pulseoximetry, and heart rate. |
Countries
Australia
Outcome results
None listed