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

NCT ID: NCT06662019

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2025-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dosing arm

Group Type: EXPERIMENTAL

N-IP-00001 inhalation solution

Intervention Type: 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).

Control

Nebulized treatment consisting of 0.9% saline solution.

Group Type: PLACEBO_COMPARATOR

0.9% NaCl isotonic saline solution

Intervention Type: DRUG

Nebulized treatment consisting of 0.9% saline solution.

Interventions

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).

Intervention Type: DRUG

0.9% NaCl isotonic saline solution

Nebulized treatment consisting of 0.9% saline solution.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NeoTrials Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Linear Clinical Research Ltd

Perth, Western Australia, Australia

Linear Clinical Research Ltd

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

CTPRO-00001

Identifier Type: -

Identifier Source: org_study_id