A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
Public ClinicalTrials.gov record NCT05629741. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05629741
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 13, 2022
- Primary completion
- Aug 1, 2024
- Completion
- Aug 1, 2024
- Last update posted
- Oct 20, 2024
2022 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Augusta University Health | Augusta | Georgia | 30912 | — |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | — |
| University of Louisville | Louisville | Kentucky | 40292 | — |
| Wayne State University | Detroit | Michigan | 48202 | — |
| Buffalo VA Medical Center | Buffalo | New York | 14215 | — |
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05629741, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2024 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05629741 live on ClinicalTrials.gov.