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CMTX-101 for Cystic Fibrosis

Phase 1 & 2
Recruiting
Research Sponsored by Clarametyx Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥18 years of age at the time of screening.
Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 35

Summary

This trial is testing a new treatment called CMTX-101 for people with cystic fibrosis. The goal is to see if it is safe and well-tolerated. The study also wants

Who is the study for?
Adults over 18 with confirmed cystic fibrosis can join this trial. They must be able to produce sputum samples, have a lung function of at least 35% or more, and use effective contraception. Participants should also have a recent history of specific antibiotic treatments for P. aeruginosa infection.
What is being tested?
The study is testing CMTX-101, an antibody designed to disrupt bacterial biofilms in cystic fibrosis patients, alongside standard antibiotics. It will check if the drug is safe, how it moves through the body (pharmacokinetics), and if it causes any immune reactions like anti-drug antibodies.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions related to monoclonal antibody infusions such as allergic responses or irritation at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition is officially diagnosed as cystic fibrosis.
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I have been on a stable dose of TRIKAFTA for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 35 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101
Number and % of participants experiencing serious adverse events following a single IV infusion of CMTX-101
Secondary study objectives
Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single IV infusion of CMTX-101
Assess the Apparent total body clearance (CL/F) determined by ELISA following a single IV infusion of CMTX-101
Assess the Apparent volume distribution (Vx/F) determined by ELISA following a single IV infustion of CMTX-101
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 5 mg/kg CMTX-101Experimental Treatment1 Intervention
5mg/kg CMTX-101 in 100mL normal saline
Group II: 30 mg/kg CMTX-101Experimental Treatment1 Intervention
30 mg/kg CMTX-101 in 100mL normal saline
Group III: 15 mg/kg CMTX-101Experimental Treatment1 Intervention
15 mg/kg CMTX-101 in 100mL normal saline
Group IV: PlaceboPlacebo Group1 Intervention
Matching placebo, 100mL normal saline

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Who is running the clinical trial?

Clarametyx Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
~7 spots leftby Feb 2025
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