NCT06659757CompletedPhase 1
A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects
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.
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 22 Oct 2024
- Start date
- 16 Oct 2024
- Primary completion date
- 14 Jul 2025
- Lead sponsor
- Kither Biotech Srl
- Diseases
- Cystic fibrosis
- NCT number
- NCT06659757
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 56
- From 16 Oct 2024 to the primary completion date, 14 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Major Inclusion Criteria:
- 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.
- Adult males and females, 18 to 55 years of age (inclusive) at screening.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.
- Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.
- Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.70.
- Major Exclusion Criteria:
- 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.
- Any respiratory infection or relevant respiratory problem within 14 days of Day 1.
- Other inclusion/exclusion eligibility criteria apply.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMAX Clinical Research Pty Ltd Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.