A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Community-acquired Pneumonia, Bacterial Pneumonia
In brief
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.
Key facts
- Study ID
- NCT05629741
- Run by
- Clarametyx Biosciences, Inc.
- People needed
- 28
- Starts
- 2022-11-14
- Expected to finish
- 2024-08-02
- Last updated by the study team
- 2024-10-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Augusta University Health — Augusta, Georgia, United States
- Snake River Research, PLLC — Idaho Falls, Idaho, United States
- University of Louisville — Louisville, Kentucky, United States
- Wayne State University — Detroit, Michigan, United States
- Buffalo VA Medical Center — Buffalo, New York, United States
- Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States
- The Ohio State University — Columbus, Ohio, United States
- University of Virginia School of Medicine — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.