A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis (NCT06159725) | Clinical Trial Compass
CompletedPhase 1/2
A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis
United States43 participantsStarted 2024-06-24
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Adults ā„18 years of age at the time of screening.
ā. If enrolled in the CFF Patient Registry, must provide registry information.
ā. Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines.
ā. For participants on modulator therapy, they must be on a stable dose of modulator therapy for at least 3 months.
ā. Willing and capable of providing induced sputum for evaluation at defined study timepoints.
ā. Positive P. aeruginosa growth of ā„104 CFU/gram from a sample of induced sputum at the screening visit.
ā. FEV1 ā„50% (Part1) or ā„35% (Part 2) of predicted normal value at screening.
ā. Currently receiving inhaled antibiotic therapy, either tobramycin or aztreonam alone, or as part of CAT. At least one 28-day cycle completed within 8 weeks prior to screening visit.
Exclusion criteria
ā. Body mass index (BMI) \<14 at screening and baseline.
What they're measuring
1
Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101
Timeframe: Day 1 to Day 28
2
Number and % of participants experiencing serious adverse events following a single IV infusion of CMTX-101