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

NCT06633757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-04-30

No results posted yet for this study

Summary

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

Conditions

  • Primary Ciliary Dyskinesia (PCD)

Interventions

DRUG

RCT1100

mRNA therapy supplied as varying dose strengths administered via oral inhalation using nebulizer

Sponsors & Collaborators

  • ReCode Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Matthews, MBBS, MCRP, PhD · ReCode Therapeutics, Inc.

  • Heymut Omran, MD · University Hospital Muenster

  • Kim G Nielsen, Dr Med Sci · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2025-06-30
Completion
2026-02-10
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633757 on ClinicalTrials.gov