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

Last updated: February 2, 2025
Sponsor: NeoTrials Pty Ltd
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

N-IP-00001 inhalation solution

0.9% NaCl isotonic saline solution

Clinical Study ID

NCT06662019
CTPRO-00001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 orsub-investigator (who is a qualified physician)through physical examination, vitalsigns 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 acceptablemaneuvres within no more than 5 attempted maneuvres. The best two values should bewithin 5% or 150mL of each other, whichever is greater.

  7. Ability to comply with study medication use, study visits, and study procedures asjudged 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

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 ofalcohol per week for males and >14 units of alcohol per week for females. Where 1unit = 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 screeningvisit or positive alcohol breath test at check-in.

  13. Not able and willing to refrain from alcohol from 24 hours before the first dosethrough study confinement

  14. Unwilling to abstain from fermented foods (kimchi, yoghurt, kefir, kombucha,sauerkraut) and strenuous exercise for 24 hours prior to dosing. Unwilling toabstain from consuming caffeine and/or xanthene products (e.g., coffee, tea,chocolate, and caffeine-containing sodas, colas) during confinement at the clinicalunit'.

  15. Participants who have received any investigational drug in a clinical research studywithin 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 Design

Total Participants: 8
Treatment Group(s): 2
Primary Treatment: N-IP-00001 inhalation solution
Phase: 1
Study Start date:
October 29, 2024
Estimated Completion Date:
January 15, 2025

Connect with a study center

  • Linear Clinical Research Ltd

    Perth, Western Australia 6009
    Australia

    Site Not Available

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