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Monoclonal Antibody for Bacterial Pneumonia

Phase 1
Recruiting
Research Sponsored by Clarametyx Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a weight of 50 to 125 kg at Screening and Day -1
Male subjects with female partners must use condoms with spermicide, surgical sterilization, or sexual abstinence
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.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is between 50 and 125 kg.
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I am a man and will use contraception or abstain from sex.
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I am 18 years old or older.
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I agree not to donate sperm during the trial.
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I agree not to have any elective surgery.
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I am hospitalized with a severe lung infection that might be CABP.
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I am a woman who cannot become pregnant because I am either surgically sterile or have gone through menopause.
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I am using a reliable form of birth control or practicing abstinence.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

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.
Group V: CMTX-101 0 mg/kgPlacebo Group1 Intervention
Placebo will be administered as a single IV infusion over 60 minutes

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Clarametyx Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

CMTX-101 2.5 mg/kg Clinical Trial Eligibility Overview. Trial Name: NCT05629741 — Phase 1
Community-acquired Pneumonia Research Study Groups: CMTX-101 2.5 mg/kg, CMTX-101 15 mg/kg, CMTX-101 30 mg/kg, CMTX-101 0 mg/kg, CMTX-101 5 mg/kg
Community-acquired Pneumonia Clinical Trial 2023: CMTX-101 2.5 mg/kg Highlights & Side Effects. Trial Name: NCT05629741 — Phase 1
CMTX-101 2.5 mg/kg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05629741 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How much risk is associated with CMTX-101 30 mg/kg dosage for patients?

"As it is a Phase 1 trial, meaning that limited evidence exists for its safety and efficacy, CMTX-101 30 mg/kg was given an assessment of 1."

Answered by AI

How many subjects are involved in the research project?

"Affirmative. Clinicaltrials.gov details show that this clinical trial, initially launched on November 14th 2022, is currently recruiting patients for participation. There are 54 positions to fill at a single medical centre."

Answered by AI

What criteria must be met for someone to enroll in this research?

"This clinical trial is seeking 54 subjects aged 18 to 65 years with a diagnosis of bacterial pneumonia. Additionally, the inclusion criteria require that participants must be able to provide voluntary informed consent, have a body mass index between 18 and 35 kg/m2, weigh 50-125 kg, demonstrate postmenopausal status or use medically accepted contraceptive methods if sexually active."

Answered by AI

Is enrollment still ongoing for this clinical investigation?

"Affirmative. As per the information provided on clinicaltrials.gov, this medical trial is looking for participants and was initially uploaded on November 14th 2022 with a subsequent update occurring three days later. A total of 54 patients from 1 site must be recruited to complete the study."

Answered by AI

What primary objectives has this investigation been designed to fulfill?

"The primary aim of this trial, which will occur between Day 1 and Day 35, is to ascertain the rate at which adverse events are experienced by healthy participants following consecutive infusions of CMTX-101. Secondary objectives include determining terminal elimination rates using ELISA testing, as well as peak plasma concentration (CMax) and time taken to reach maximum concentration (TMax)."

Answered by AI

Does the research include participants aged over 35?

"This medical trial has some specific patient requirements, with participants needing to be aged between 18 and 65. For those under 18 or over 65, there are 28 and 150 trials respectively that may meet their needs."

Answered by AI
~2 spots leftby May 2024