A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
Status:
Recruiting
Trial end date:
2024-02-07
Target enrollment:
Participant gender:
Summary
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.