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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05737485). StuddyBuddy aggregates publicly available trial information.