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Monoclonal Antibody for Bacterial Pneumonia

Phase 1

Waitlist Available

Research Sponsored by Clarametyx Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohorts 1 and 2: day 1 to day 29. cohorts 3 and 4: day 1 to day 100.

Summary

This trial studies a new monoclonal antibody to treat moderate bacterial pneumonia, to assess its safety and how it interacts with other antibiotics.

Who is the study for?

This trial is for healthy volunteers and patients with moderate community-acquired bacterial pneumonia (CABP). Participants must be adults in good health or have CABP requiring hospitalization, with a BMI of 18-45 kg/m2. Women must be non-childbearing or use contraception; men agree to avoid sperm donation post-trial. Exclusions include abnormal lab values, severe allergies, recent investigational drug/vaccine use, mechanical ventilation need, severe immunosuppression, substance abuse, and certain infections.

What is being tested?

The study tests CMTX-101's safety and how the body processes it when given as an IV infusion alongside standard antibiotics. It will also look at whether the treatment causes any immune response against itself. The first part involves healthy volunteers receiving ascending doses of CMTX-101; the second part includes patients with CABP.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to monoclonal antibodies such as infusion-related reactions (like fever or chills), allergic responses, possible organ inflammation due to immune system activation by the antibody therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohorts 1 and 2: day 1 to day 29. cohorts 3 and 4: day 1 to day 100.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cohorts 1 and 2: day 1 to day 29. cohorts 3 and 4: day 1 to day 100.

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohorts 1 and 2: day 1 to day 29. cohorts 3 and 4: day 1 to day 100. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion

Number and % of healthy subjects experiencing Serious Adverse Events following ascending doses of a single CMTX-101 IV infusion

Number and % of healthy subjects experiencing Solicited Adverse Events following ascending doses of a single CMTX-101 IV infusion

+3 more

Secondary study objectives

Assess the AUC0-last Area under the concentration time curve following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity

Assess the AUC0-last Area under the concentration time curve following ascending doses of a single CMTX-101 IV infusion in healthy subjects

Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity

+15 more