NCT06159725

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

A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Antibiotics In People With Cystic Fibrosis Chronically Infected With Pseudomonas Aeruginosa

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Clarametyx Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Persistent Infection
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	CMTX-101	CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.
DRUG	Placebo	Placebo is normal saline administered as a single IV infusion over approximately 60 minutes.

Timeline

• Start date: 2024-06-24
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2023-12-07
• Last updated: 2025-11-21

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study