Study of Inhaled RCT1100 in Adults With PCD Caused by Pathogenic Mutations in the DNAI1 Gene to Measure Mucociliary Clearance

Completed · Phase 1

Conditions studied: Primary Ciliary Dyskinesia (PCD)

In brief

This is a multi-dose study with RCT1100 and is designed to provide safety, tolerability and preliminary efficacy data for future clinical studies.

Key facts

Study ID: NCT06633757
Run by: ReCode Therapeutics
People needed: 14
Starts: 2024-10-22
Expected to finish: 2026-02-10
Last updated by the study team: 2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
History of cancer, with exception of adequately treated basal cell or squamous cell carcinoma of the skin.
Predisposition to bleeding or clinically meaningful hemorrhagic event in the 12 months prior
Medically significant hemoptysis.
Anticoagulation therapy for the treatment of a pulmonary embolus or has had a pulmonary embolus in the last 6 months of screening.
Active tuberculosis infection.
12-lead ECG with QT interval \&gt;450 msec (or \&gt;480 msec for BBB)
Laboratory abnormalities in clinical laboratory tests at screening:
Serum creatinine level
Total bilirubin, aspartate aminotransferase or alanine aminotransferase values
Hematological or coagulation values outside the normal reference range
Any medical history of disease that has the potential to cause a rise in total bilirubin over the ULN.
COVID-19 infection within 4 weeks of Screening or receipt of COVID-19 vaccine within 2 weeks prior to first dose of RCT1100.
Receipt of vaccine with live virus, attenuated live virus, or live viral components within 2 weeks prior to first dose of RCT1100 or to receive these vaccines during treatment or within 8 weeks of completion of study treatment.
Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

UNC — Chapel Hill, North Carolina, United States
Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark
Münster University Hospital, Albert-Schweitzer-Campus 1 — Münster, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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