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

NCT06662019 | Completed Phase 1

• 1 other identifier: CTPRO-00001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

safety; tolerability; inhalation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Dosing arm

EXPERIMENTAL

Drug: N-IP-00001 inhalation solution

Control

PLACEBO COMPARATOR

Nebulized treatment consisting of 0.9% saline solution.

Drug: 0.9% NaCl isotonic saline solution

Interventions

N-IP-00001 inhalation solution DRUG

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).

Dosing arm

0.9% NaCl isotonic saline solution DRUG

Nebulized treatment consisting of 0.9% saline solution.

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years and ≤ 55 years.
• Male or non-pregnant, non-lactating Female
• 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.
• No current acute or chronic respiratory conditions.
• FEV1 ≥ 80% predicted.
• 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.
• Ability to comply with study medication use, study visits, and study procedures as judged by the investigator.
• Able to understand and sign an informed consent.
• Non-smoker and has not smoked for at least 6 months.

You may not qualify if:

• 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 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.
• 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 screening visit or positive alcohol breath test at check-in.
• Not able and willing to refrain from alcohol from 24 hours before the first dose through study confinement
• 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'.
• 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.

Sponsors & Collaborators

• NeoTrials Pty Ltd: lead

Study Sites (2)

Linear Clinical Research Ltd

Perth, Western Australia, 6009, Australia

Location

Linear Clinical Research Ltd

Perth, Western Australia, 6027, Australia

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: October 29, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

AU (2)