bacterial DNABII

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunctive therapy to standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in people with cystic fibrosis (pwCF).
The main questions the study aims to answer are:
* Are single doses of CMTX-101 IV infusion safe and tolerated
* What is the pharmacokinetic (PK) profile of single doses of CMTX-101
* Do single doses of CMTX-101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs)

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunct therapy with standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in healthy volunteers followed by a similar assessment in patients with suspected or confirmed community acquired bacterial pneumonia of moderate severity.
The main questions the study aims to answer are:
* Are single ascending doses of a CMTX-101 intravenous (IV) infusion safe and tolerated
* What is the pharmacokinetic (PK) profile of single-ascending doses CMTX 101
* Do single ascending doses of CMTX 101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs)
Exploratory efficacy biomarkers will also be measured in the patient part of the study. Participants will be administered a single IV infusion of CMTX-101 over a 60-minute period; patients will receive the infusion after starting standard of care antibiotics.