HealthyPhase 1NCT06662019
Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.
A Phase 1 study testing N-IP-00001 inhalation solution and 0.9% NaCl isotonic saline solution in people with Healthy, run by NeoTrials Pty Ltd at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- N-IP-00001 inhalation solution and 0.9% NaCl isotonic saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 Oct 2024to 15 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Failure to satisfy the investigator of fitness to participate for any other reason.
- Currently taking any medication by the inhaled route.
- Those with commercial interest in the product or related products.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Linear Clinical Research Ltd
Perth, Western Australia, 6009
Linear Clinical Research Ltd
Perth, Western Australia, 6027
About this study
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.
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
- Being tested
- N-IP-00001 inhalation solution, 0.9% NaCl isotonic saline solution
- Keywords
- safety, tolerability, inhalation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-IP-00001 inhalation solutionDrug
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).
0.9% NaCl isotonic saline solutionDrug
Nebulized treatment consisting of 0.9% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Dosing arm | Experimental | Not described Receives: Drug: N-IP-00001 inhalation solution |
| Control | Placebo comparator | Nebulized treatment consisting of 0.9% saline solution. Receives: Drug: 0.9% NaCl isotonic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 2 weeks
FEV1 measured by spirometry
Measured: Up to 2 weeks
Changes in vital signs
Changes in blood pressure, temperature, pulseoximetry, and heart rate.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start29 Oct 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoTrials Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662019
- Sponsor's protocol ID
- CTPRO-00001
- Status last verified
- Feb 2025
- First submitted
- 24 Oct 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06662019
- Acronym / sponsor ID
- CTPRO-00001
- Conditions
- Healthy
- Keywords
- safety, tolerability, inhalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeoTrials Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosing arm | Experimental | Drug: N-IP-00001 inhalation solution |
| Control | Placebo comparator | Drug: 0.9% NaCl isotonic saline solutionNebulized treatment consisting of 0.9% saline solution. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-IP-00001 inhalation solutionMultiple 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). | Drug | Dosing arm |
| 0.9% NaCl isotonic saline solutionNebulized treatment consisting of 0.9% saline solution. | Drug | Control |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 2 weeks
FEV1 measured by spirometry
Time frame: Up to 2 weeks
Changes in vital signs
Time frame: Up to 2 weeks
Changes in blood pressure, temperature, pulseoximetry, and heart rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-IP-00001 inhalation solution and 0.9% NaCl isotonic saline solution in people with Healthy, run by NeoTrials Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.