NCT06747858

Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis

A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Arcturus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.

Detailed description

This is an open-label, multiple-ascending dose study of ARCT-032 in adults with CF who are not on CFTR modulator therapy. After successful screening, eligible participants will receive nebulized ARCT-032 daily for 4 weeks, and then followed for safety for a total of 12 weeks.

Conditions

• Cystic Fibrosis
• CFTR Gene Mutation

Interventions

Type	Name	Description
BIOLOGICAL	ARCT-032	CFTR mRNA formulated in lipid nanoparticles

Timeline

• Start date: 2024-12-12
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-24
• Last updated: 2025-10-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study