This is a double-blind, randomized, placebo-controlled study of CMTX-101 in pwCF who are 18 years of age or older and chronically infected with P. aeruginosa. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 in up to 41 participants. This study has 2 parts.

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).

If you have been diagnosed with NTM, then your doctor may decide that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to you in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because you have a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because you have had side effects that prevent the use of other drugs.

The CF Patient Registry is an observational study. It does not involve medical treatments and serves only as an epidemiologic record of demographics, characteristics of disease and treatment, utilization patterns, and clinical outcomes.