A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
- Conditions
- Community-acquired PneumoniaBacterial Pneumonia
- Interventions
- Drug: Placebo
- Registration Number
- NCT05629741
- Lead Sponsor
- Clarametyx Biosciences, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CMTX-101 5 mg/kg CMTX-101 CMTX-101 will be administered as a single IV infusion over 60 minutes. CMTX-101 2.5 mg/kg CMTX-101 CMTX-101 will be administered as a single IV infusion over 60 minutes. CMTX-101 0 mg/kg Placebo Placebo will be administered as a single IV infusion over 60 minutes CMTX-101 30 mg/kg CMTX-101 CMTX-101 will be administered as a single IV infusion over 60 minutes. CMTX-101 15 mg/kg CMTX-101 CMTX-101 will be administered as a single IV infusion over 60 minutes.
- Primary Outcome Measures
Name Time Method Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Primary objective of Part 1
Number and % of hospitalized subjects with suspected or confirmed CABP of moderate severity experiencing Serious Adverse Events following dosing of a single CMTX-101 IV infusion Day 1 to Day 35 Primary objective of Part 2
Number and % of hospitalized subjects with suspected or confirmed CABP of moderate severity experiencing Solicited Adverse Events following dosing of a single CMTX-101 IV infusion Day 1 to Day 35 Primary objective of Part 2
Number and % of healthy subjects experiencing Serious Adverse Events following ascending doses of a single CMTX-101 IV infusion Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Primary objective of Part 1
Number and % of hospitalized subjects with suspected or confirmed CABP of moderate severity experiencing Adverse Events following dosing of a single CMTX-101 IV infusion Day 1 to Day 35 Primary objective of Part 2
Number and % of healthy subjects experiencing Solicited Adverse Events following ascending doses of a single CMTX-101 IV infusion Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Primary objective of Part 1
- Secondary Outcome Measures
Name Time Method Assess the AUC0-last Area under the concentration time curve following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the Terminal elimination half-determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies (ADAs) determined by electrochemiluminescence assay following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the Terminal phase elimination rate determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the AUC0-last Area under the concentration time curve following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the TMax - Time to reach maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the Terminal phase elimination rate determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the Apparent volume of distribution (Vz/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the CMax - Observed maximum plasma concentration determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the TMax - Time to reach maximum plasma concentration determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the Apparent total body clearance (CL/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Assess the Terminal elimination half-determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the Apparent volume of distribution (Vz/F) determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies determined by electrochemiluminescence assay following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the Apparent total body clearance (CL/F) determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity Day 1 to Day 35 Secondary objective of Part 2
Assess the CMax - Observed maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100. Secondary objective of Part 1
Trial Locations
- Locations (8)
The Ohio State University
🇺🇸Columbus, Ohio, United States
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
University of Virginia School of Medicine
🇺🇸Charlottesville, Virginia, United States