Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects
Primary Ciliary Dyskinesia
About this trial
This is an interventional treatment trial for Primary Ciliary Dyskinesia focused on measuring Primary Ciliary Dyskinesia, PCD, Kartagener Syndrome
Eligibility Criteria
Major Inclusion Criteria: Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening. Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening, and a total body weight ≥ 50 kg 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.
Sites / Locations
- New Zealand Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
RCT1100
Placebo
Drug: RCT1100 single dose
Drug: Placebo single dose