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

NeoTrials Pty Ltd

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 0.9% NaCl isotonic saline solution; Drug: N-IP-00001 inhalation solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06662019

CTPRO-00001

Details and patient eligibility

About

Randomized, double-blind, placebo-controlled, dose-escalation Phase I safety study of inhaled N-IP-00001, to determine tolerability and safety in healthy volunteers.

Enrollment: 8 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Dosing arm

Experimental group

Treatment:

Drug: N-IP-00001 inhalation solution

Control

Placebo Comparator group

Description:

Nebulized treatment consisting of 0.9% saline solution.

Treatment:

Drug: 0.9% NaCl isotonic saline solution