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

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.

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: N-IP-00001 inhalation solution; Drug: 0.9% NaCl isotonic saline solution

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Linear Clinical Research Ltd
    • Perth, Western Australia, Australia, 6027
      • Linear Clinical Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing arm	Drug: N-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).
Placebo Comparator: Control; Nebulized treatment consisting of 0.9% saline solution.	Drug: 0.9% NaCl isotonic saline solution; Nebulized treatment consisting of 0.9% saline solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Changes in blood pressure, temperature, pulseoximetry, and heart rate.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: NeoTrials Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: tolerability; safety; inhalation
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CTPRO-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No