Monoclonal Antibody for Bacterial Pneumonia

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Clarametyx Biosciences, Inc.

Stay on Your Current Meds

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My weight is between 50 and 125 kg.

I am a man and will use contraception or abstain from sex.

For Part 1 (healthy volunteers): Agrees to stay in contact with the site and provide updated contact information

See 11 more

Exclusion Criteria

Has a history or evidence of an allergic reaction that may compromise safety

Has abnormal 12-lead ECG or QTcF values

My immune system is very weak.

See 16 more

Treatment Details

Interventions

CMTX-101 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: CMTX-101 5 mg/kgExperimental Treatment1 Intervention

CMTX-101 will be administered as a single IV infusion over 60 minutes.

Group II: CMTX-101 30 mg/kgExperimental Treatment1 Intervention

CMTX-101 will be administered as a single IV infusion over 60 minutes.

Group III: CMTX-101 2.5 mg/kgExperimental Treatment1 Intervention

CMTX-101 will be administered as a single IV infusion over 60 minutes.

Group IV: CMTX-101 15 mg/kgExperimental Treatment1 Intervention

CMTX-101 will be administered as a single IV infusion over 60 minutes.