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Monoclonal Antibody for Bacterial Pneumonia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- My weight is between 50 and 125 kg.I am a man and will use contraception or abstain from sex.My immune system is very weak.I am 18 years old or older.I have received treatments or have conditions related to community-acquired bacterial pneumonia.My lung issues are not caused by an infection.I agree not to donate sperm during the trial.I am generally in good health.I agree not to have any elective surgery.I am a woman who cannot become pregnant because I am either surgically sterile or have gone through menopause.I have received immunoglobulin or blood products in the last 4 months.I have or might have viral pneumonia.I have specific conditions related to community-acquired bacterial pneumonia.I am using a reliable form of birth control or practicing abstinence.I don't have any other serious illnesses that could affect my safety in the trial.I have or might have a serious infection or cancer affecting my lungs or other parts.I have been diagnosed with HIV.I have a history of chronic hepatitis B or active hepatitis C.I am hospitalized with a severe lung infection that might be CABP.I am of childbearing age and have a negative pregnancy test.
- Group 1: CMTX-101 2.5 mg/kg
- Group 2: CMTX-101 15 mg/kg
- Group 3: CMTX-101 30 mg/kg
- Group 4: CMTX-101 0 mg/kg
- Group 5: CMTX-101 5 mg/kg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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)."
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."
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