Safety and Efficacy of ARCT-032 for Cystic Fibrosis
This study is testing a new treatment called ARCT-032 for adults with Cystic Fibrosis (CF). ARCT-032 is a biological treatment that uses mRNA (messenger RNA) delivered in tiny fat particles. We want to see how safe ARCT-032 is, if people can tolerate it, and if it helps improve CF symptoms. You might be able to join if you have a confirmed CF diagnosis, are 18 or older, and are not currently taking other CFTR modulator therapies (for example, due to side effects or lack of access). The study will look at any side effects and how severe they are over 16 or 24 weeks. The current status of this study is unclear, and it plans to enroll 33 participants.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving ARCT-032. It is a multiple-ascending dose study, which means different groups of participants will receive increasing doses of the treatment. The study plans to enroll 33 participants.
- What's involved
- If you join, you would receive ARCT-032 daily through a nebulizer for either 4 weeks (Cohorts 1-3) or 12 weeks (Cohort 4).
- Compensation
- Not stated in the trial record.
- Follow-up
- After receiving ARCT-032, participants in Cohorts 1-3 will be followed for safety for a total of 12 weeks. Participants in Cohort 4 will be followed for safety for an additional 12 weeks after their 12 weeks of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
At a glance
Conditions
Where it's being run
13 sites across 13 statesWho to contact
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What this trial measures
- Incidence, severity and dose relationship of adverse eventsCohorts 1-3: 16 weeks and Cohort 4: 24 weeks
Safety and tolerability of ARCT-032 assess by determining incidence, severity and dose-relationship of AEs by dose level