drugset / Trial / NCT06159725

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis

NCT06159725 ↗

Phase 1/2 Completed 43 enrolled Clarametyx Biosciences, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

Start
2024-06-24
Primary completion
2025-11-14
Completion
2025-11-14

Outcome

Met primary endpoint

release “Study met its primary endpoint demonstrating safety and tolerability of CMTX-101 in people with cystic fibrosis” clarametyx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CMTX-101 Monoclonal antibody 5 mg/kg Intravenous
Subject CMTX-101 Monoclonal antibody 15 mg/kg Intravenous
Subject CMTX-101 Monoclonal antibody 30 mg/kg Intravenous

Indications