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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.
Placebo is normal saline administered as a single IV infusion over approximately 60 minutes.
University of Alabama, Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Franciso, California, United States
National Jewish Health
Denver, Colorado, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
St Luke's Sleep Medicine and Research Center
Boise, Idaho, United States
Cystic Fibrosis Institute
Northfield, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
...and 13 more locations
Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101
Primary objective
Time frame: Day 1 to Day 28
Number and % of participants experiencing serious adverse events following a single IV infusion of CMTX-101
Primary objective
Time frame: Day 1 to Day 28
Assess the CMax - observed maximum plasma concentration determined by ELISA following a single IV infustion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the TMax - time to reach maximum concentration curve following a single IV infusion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single IV infusion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the Terminal phase elimination rate determined by ELISA following a single IV infusion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the Terminal elimination half- determined by ELISA following a single IV infusion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the Apparent total body clearance (CL/F) determined by ELISA following a single IV infusion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the Apparent volume distribution (Vx/F) determined by ELISA following a single IV infustion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies (ADA) determined by the electrochemiluminescence assay following a single IV infustion of CMTX-101
Secondary objective
Time frame: Day 1 to Day 35
Assess the apparent reduction in pulmonary P. auriginosa burden as measured by quantitative microbial culture of sputum
Secondary objective
Time frame: Day 1 to Day 28
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