CompletedPhase 1

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

Australia8 participantsStarted 2024-10-29

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to 2 weeks

FEV1 measured by spirometry

Timeframe: Up to 2 weeks

Changes in vital signs

Timeframe: Up to 2 weeks

Trial details

NCT IDNCT06662019

SponsorNeoTrials Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-15

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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