Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2025-12-21
• Target enrollment: 0
• Participant gender: All

Summary

This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ReCode Therapeutics

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.