A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects

A regiszterben nem jelölt feltételek

• 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.