RCT1100 for Primary Ciliary Dyskinesia
Recruiting at 4 trial locations
PR
CM
CV
Overseen ByCathy Vo Buu
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: ReCode Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.
Research Team
JM
John Matthews, MBBS, MCRP, PhD
Principal Investigator
ReCode Therapeutics, Inc.
Eligibility Criteria
This trial is for healthy adults aged 18-55 who are not able to have children. Participants should be in good health as judged by medical history, lab tests, heart checks (ECG), and physical exams. They must understand the study's procedures, agree to follow them, have a BMI between 18 and 35 kg/m2, weigh at least 50 kg, and have normal lung function (FEV1 of at least 80% predicted).Inclusion Criteria
My BMI is between 18 and 35, and I weigh at least 50 kg.
I am a healthy adult between 18-55 years old and cannot have children.
You can forcefully exhale at least 80% of the predicted volume in one second.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single ascending dose of inhaled RCT1100 via nebulizer
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
180 days
Treatment Details
Interventions
- Placebo
- RCT1100
Trial Overview The trial is testing RCT1100 for safety and how well it's tolerated in people. It's the first time this drug is being given to humans with the goal of gathering early data that will help design future studies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: RCT1100Experimental Treatment1 Intervention
Drug: RCT1100 single dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
ReCode Therapeutics
Lead Sponsor
Trials
6
Recruited
390+
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