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NCT05737485
Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects
Conditions: Primary Ciliary Dyskinesia
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 32
Sponsor: ReCode Therapeutics
Summary
This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.
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 kgThe participant has a forced expiratory volume in one second (FEV1) of at least 80% predictedThe 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.
Source: ClinicalTrials.gov (NCT05737485). StuddyBuddy aggregates publicly available trial information.