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A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101

A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101, an Anti-DNABII Monoclonal Antibody, in Healthy Subjects (Part 1) and Hospitalized Subjects with Suspected or Confirmed Community-Acquired Bacterial Pneumonia of Moderate Severity (Part 2)

NCT05629741•Clarametyx Biosciences, Inc.

View on ClinicalTrials.gov

Summary

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunct therapy with standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in healthy volunteers followed by a similar assessment in patients with suspected or confirmed community acquired bacterial pneumonia of moderate severity. The main questions the study aims to answer are: * Are single ascending doses of a CMTX-101 intravenous (IV) infusion safe and tolerated * What is the pharmacokinetic (PK) profile of single-ascending doses CMTX 101 * Do single ascending doses of CMTX 101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs) Exploratory efficacy biomarkers will also be measured in the patient part of the study. Participants will be administered a single IV infusion of CMTX-101 over a 60-minute period; patients will receive the infusion after starting standard of care antibiotics.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Is ≥ 18 years of age at Screening;
•2. Is able to provide written informed consent;
•3. If a female subject of non-childbearing potential, is either surgically sterile (i.e., has had a hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or post-menopausal, defined as spontaneous amenorrhea for at least 2 years, with a follicle-stimulating hormone in the post-menopausal range obtained during Screening;
•4. Contraceptive requirements: If a female subject of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) with a male partner or a male subject with a female partner, must use a medically accepted contraceptive regimen during her/his participation in the study and for 4 months after the last infusion of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
•Acceptable methods of contraception for male subjects include the following:
•1. Condoms with spermicide;
•2. Surgical sterilization of subject (i.e., vasectomy) at least 26 weeks before Screening; or
•3. Sexual abstinence (i.e., refraining from heterosexual intercourse), if the preferred and usual lifestyle of the subject.
•Acceptable methods of contraception for female subjects include the following:
•4. Bilateral tubal ligation, completed at least 12 weeks prior to Screening;
+18 more criteria

Exclusion Criteria

•1. Has a history or evidence of systemic autoimmune disease;
•2. Has received immunoglobulin or blood products within 120 days prior to Screening;
•3. Has a known history or evidence of HIV infection;
•4. Has a known history or evidence of chronic hepatitis B defined as persistent hepatitis B surface antigen for \>6 months, or has an active hepatitis C virus (HCV) infection, defined as positive HCV RNA; Note: Patients with positive HCV antibodies and negative HCV RNA will be permitted.
•5. Has a positive test for drugs of abuse at Screening (both parts) or Day -1 (Part 1);
•6. Is participating, plans to participate during the study period, or has participated within the last 30 days prior to Screening in any other investigational study;
•7. Has received an investigational drug or live vaccine within 30 days or 5 half-lives of the investigational compound, whichever is longer, prior to Screening;
•8. Is currently pregnant or lactating/nursing;
•9. Has a history or evidence of an allergic reaction that, in the opinion of the Investigator, may compromise the safety of the subject;
•10. Has a known or suspected hypersensitivity to CMTX-101 or its excipients;
+35 more criteria

Locations (8)

Augusta University Health

Augusta, Georgia, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

University of Louisville

Louisville, Kentucky, United States

Wayne State University

Detroit, Michigan, United States

Buffalo VA Medical Center

Buffalo, New York, United States

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Key Dates

Start Date

November 14, 2022

Primary Completion Date

August 2, 2024

Completion Date

August 2, 2024

Last Updated

October 21, 2024

Enrollment

ACTUAL participants

Conditions

Community-acquired PneumoniaBacterial Pneumonia

Interventions

CMTX-101

DRUG

Placebo

DRUG

The Fever Clinic Acute Respiratory Cohort

NCT07278700

Acute Respiratory InfectionsFebrile Illnesses+3 more

View study

RECRUITINGPHASE4

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

NCT06295120

Community-acquired Pneumonia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101

Inclusion Criteria

Exclusion Criteria

The Fever Clinic Acute Respiratory Cohort

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)

Optimising TREATment for Severe Gram-Negative Bacterial Infections

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP