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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)

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Trial Profile

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)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs CMTX 101 (Primary)
  • Indications Community-acquired pneumonia; Otitis media
  • Focus Adverse reactions; First in man
  • Sponsors Clarametyx Biosciences

    • Most Recent Events

    • 21 Oct 2024 Status changed from recruiting to discontinued ( due to slow enrollment. No safety issues were identified. Part 1 (healthy volunteers) fully enrolled; Part 2 (CABP patients) enrolled the first 2 cohorts. Data currently under review. Results will be posted when final. ).
    • 12 Jan 2024 Planned End Date changed from 7 Feb 2024 to 11 May 2024.
    • 12 Jan 2024 Planned primary completion date changed from 7 Feb 2024 to 11 May 2024.

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