Clinical trial NCT06662019: Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
inhalation
Lead sponsor: NeoTrials Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 2 weeks
measure: FEV1 measured by spirometry
timeFrame: Up to 2 weeks
measure: Changes in vital signs
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
city: Perth
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
Study officials:
References: