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

NCT05629741 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-10-21

No results posted yet for this study

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.

Conditions

  • Community-acquired Pneumonia
  • Bacterial Pneumonia

Interventions

DRUG

CMTX-101

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Sponsors & Collaborators

  • Clarametyx Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2024-08-02
Completion
2024-08-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629741 on ClinicalTrials.gov