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30 mg/kg 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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 35

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clarametyx Biosciences, Inc.Lead Sponsor

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this ongoing clinical trial?

"As per the latest information on clinicaltrials.gov, this trial is not actively seeking participants. Its initial posting was made on January 1st, 2024 and it was last updated on January 18th, 2024. However, there are currently numerous other ongoing trials (specifically 393) that are actively recruiting patients at present."

Answered by AI

What are the objectives of this particular research endeavor?

"The primary objective of this clinical trial is to determine the number and percentage of participants who experience serious adverse events after receiving a single intravenous infusion of CMTX-101 within a 28-day timeframe. Secondary objectives include evaluating the observed maximum plasma concentration (CMax) through ELISA testing, assessing the apparent volume distribution (Vx/F) through ELISA testing, and determining the terminal elimination half-life through ELISA testing following a single intravenous infusion of CMTX-101."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159725.

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