Overview
This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.
Description
The primary objective of this study is to assess the safety, tolerability, and biodistribution of a single ascending dose of inhaled RCT2100 administered via nebulizer to healthy participants
Eligibility
Major Inclusion Criteria:
- Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
- Body weight greater than or equal to 50 kg and body mass index (BMI) between 16-32 kg/m2, inclusive
- The participant has a forced expiratory volume in one second (FEV1) of at least 80% predicted
- The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
Major Exclusion Criteria:
- History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
- The participant has supine blood pressure (BP) >150 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- The participant has abnormal clinical laboratory tests at screening, as assessed by the study-specific laboratory.
- The participant is a smoker or has used nicotine or nicotine-containing products 6 weeks before the first dose of study drug. Former smokers with greater than 10 pack years of smoking history are excluded.