Cystic Fibrosis
Conditions
Brief summary
This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.
Detailed description
This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).
Interventions
DRUGKIT2014
KIT2014 will be administered by inhalation with a nebuliser
OTHERPlacebo
Placebo will be administered by inhalation with a nebuliser
Sponsors
Avance Clinical Pty Ltd.
Kither Biotech Srl
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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 ≥0.70. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) | Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD | Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants. |
Countries
Australia
Outcome results
None listed