RCT2100 for Cystic Fibrosis

Recruiting at24 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: ReCode Therapeutics

Must not be taking: CFTR modulators

Disqualifiers: Hypertension, Smoking, Hepatic impairment, others

Trial Summary

What is the purpose of this trial?

This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.

Will I have to stop taking my current medications?

The trial requires that participants not use CFTR modulators (specific cystic fibrosis medications) within 12 weeks before screening. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Research Team

John Matthews, MBBS, MCRP, PhD

Principal Investigator

ReCode Therapeutics, Inc.

Eligibility Criteria

This trial is for healthy adults aged 18-55, weighing at least 50 kg with a BMI of 16-32. Participants must have good lung function (FEV1 of at least 80% predicted) and be in overall good health as determined by various medical assessments. They need to understand the study procedures and agree to follow the protocol.

Inclusion Criteria

Understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol

Forced expiratory volume in one second (FEV1) of at least 80% predicted

I am a healthy adult between 18 and 55 years old.

Exclusion Criteria

Supine blood pressure (BP) >150 mm Hg (systolic) or >90 mm Hg (diastolic) after at least 5 minutes of rest

Abnormal clinical laboratory tests at screening as assessed by the study-specific laboratory

Arterial oxygen saturation on room air less than 94% at screening

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Single ascending dose of inhaled RCT2100 administered via nebulizer to healthy participants

4 weeks

1 visit (in-person)

Treatment Part 2

Multiple ascending doses of inhaled RCT2100 administered to participants with CF

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

• RCT2100 (Other)

Trial Overview The trial is testing RCT2100, a new medication, on both healthy participants and those with Cystic Fibrosis. It aims to assess safety and tolerability. Some people will receive RCT2100 while others will get a placebo (a substance with no therapeutic effect) for comparison.

Participant Groups

Group I: RCT2100 (Part 2) 4 week Experimental Treatment 1 Intervention

RCT2100 multiple dose

Group II: RCT2100 (Part 2) 12 week Experimental Treatment 1 Intervention

RCT2100 multiple dose

Group III: RCT2100 (Part 1) Experimental Treatment 1 Intervention

RCT2100 single dose

Group IV: Placebo (Part 1) Placebo Group 1 Intervention

Placebo single dose

Who Is Running the Clinical Trial?

ReCode Therapeutics

Lead Sponsor

Trials

6

Recruited

390+