NCT05668741
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
Active, Not Recruiting
PHASE1Ages 18–65InterventionalTreatmentVertex Pharmaceuticals Incorporated
~26 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:VX-522 mRNA therapyIVA
At a glance
Recruiting sites
0 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From Day 1 Through Week 8 [SAD and MAD]
Conditions
Where it's being run
26 sites across 17 statesUnited Kingdom6
California2
Maryland2
Massachusetts2
Canada2
Alabama1
Colorado1
Kansas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Body mass index is less than (\<) 30.0 kilograms per meter square (kg/m\^2)
A total body weight greater than (\>) 50 kg
Stable CF disease
CFTR gene mutations on both alleles that are not responsive to CFTR modulator therapy
Forced expiratory volume in 1 second (FEV1) value for SAD: greater than or equal to (≥)40 percent (%), MAD: ≥ 50% to less than or equal to (≤) 90%
Exclusion
History of uncontrolled asthma within a year prior to screening
History of solid organ or hematological transplantation
Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
Arterial oxygen saturation on room air less than (\<) 94% at screening
What this trial measures
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day 1 Through Week 8 [SAD and MAD]