Investigating the safety of KIT2014 in healthy adults
A Single-Centre, Double-Blinded, Randomised, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects.
This study is testing a new inhaled medication called KIT2014 in healthy adults to see if it's safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Kither Biotech Srl Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT06659757 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety, tolerability, and pharmacokinetics of KIT2014, an inhaled medication, in healthy adult volunteers. The study is structured in two parts: a single ascending dose (SAD) and a multiple ascending dose (MAD) phase, both conducted in a double-blind, randomized, placebo-controlled manner. Participants will receive either the KIT2014 treatment or a placebo via nebulizer, allowing researchers to gather critical data on the drug's effects and safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with normal lung function and no significant medical history.
Not a fit: Patients with existing significant health conditions or respiratory infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new treatment option for patients with cystic fibrosis.
How similar studies have performed: While this is a first-in-human study, similar approaches in assessing inhaled medications have shown promise in other trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Major Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females. 4. Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities. 5. Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.7. Major Exclusion Criteria: 1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI to be clinically relevant. 2. Any respiratory infection or relevant respiratory problem within 14 days of Day 1. Other inclusion/exclusion eligibility criteria apply.
Where this trial is running
Adelaide, South Australia
- CMAX Clinical Research Pty Ltd — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Tony Le, MD
- Email: Tony.le@cmax.com.au
- Phone: +61 0449 044 697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.