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

February 2, 2025 updated by: NeoTrials Pty Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 2 weeks
Up to 2 weeks
FEV1 measured by spirometry
Time Frame: Up to 2 weeks
Up to 2 weeks
Changes in vital signs
Time Frame: Up to 2 weeks
Changes in blood pressure, temperature, pulseoximetry, and heart rate.
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NeoTrials Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on N-IP-00001 inhalation solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings