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

Launched by KITHER BIOTECH SRL · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called KIT2014 to see how safe it is and how well it is tolerated by healthy volunteers. The goal is to gather important information about how the medication behaves in the body. This is the first time KIT2014 is being tested in humans, and it involves giving participants either a single dose or multiple doses of the drug to understand its effects.

To participate in this study, volunteers need to be healthy adults between the ages of 18 and 55, with a certain weight range and normal lung function. People with significant medical conditions or recent respiratory infections will not be eligible. If you join the study, you can expect close monitoring by medical professionals and will be asked to report any side effects you may feel. Your safety is the top priority in this trial, and all participants will provide informed consent before starting.

Gender

ALL

Eligibility 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.