A Phase 1 Study of VX-522 in Participants With Cystic Fibrosis (CF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05668741|
Recruitment Status : Recruiting
First Posted : December 30, 2022
Last Update Posted : November 1, 2023
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: VX-522 mRNA therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Single Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy|
|Actual Study Start Date :||February 27, 2023|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Participants will receive a single dose of different dose levels of VX-522.
Drug: VX-522 mRNA therapy
Oral inhalation using nebulizer.
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day 1 Through Safety Follow-up Visit (Week 24) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05668741
|Contact: Medical Informationfirstname.lastname@example.org|