A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunog… (NCT05629741) | Clinical Trial Compass
TerminatedPhase 1
A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
Stopped: Study was stopped due to slow enrollment. No safety issues were identified. Part 1 (healthy volunteers) fully enrolled; Part 2 (CABP patients) enrolled the first 2 cohorts. Data currently under review. Results will be posted when final.
United States28 participantsStarted 2022-11-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is ≥ 18 years of age at Screening;
. Is able to provide written informed consent;
. If a female subject of non-childbearing potential, is either surgically sterile (i.e., has had a hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or post-menopausal, defined as spontaneous amenorrhea for at least 2 years, with a follicle-stimulating hormone in the post-menopausal range obtained during Screening;
. Contraceptive requirements: If a female subject of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) with a male partner or a male subject with a female partner, must use a medically accepted contraceptive regimen during her/his participation in the study and for 4 months after the last infusion of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
. Condoms with spermicide;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion
Timeframe: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
2
Number and % of healthy subjects experiencing Serious Adverse Events following ascending doses of a single CMTX-101 IV infusion
Timeframe: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
3
Number and % of healthy subjects experiencing Solicited Adverse Events following ascending doses of a single CMTX-101 IV infusion
Timeframe: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
4
Number and % of hospitalized subjects with suspected or confirmed CABP of moderate severity experiencing Adverse Events following dosing of a single CMTX-101 IV infusion
Timeframe: Day 1 to Day 35
5
Number and % of hospitalized subjects with suspected or confirmed CABP of moderate severity experiencing Serious Adverse Events following dosing of a single CMTX-101 IV infusion
Timeframe: Day 1 to Day 35
6
Number and % of hospitalized subjects with suspected or confirmed CABP of moderate severity experiencing Solicited Adverse Events following dosing of a single CMTX-101 IV infusion
. Surgical sterilization of subject (i.e., vasectomy) at least 26 weeks before Screening; or
. Sexual abstinence (i.e., refraining from heterosexual intercourse), if the preferred and usual lifestyle of the subject.
. Bilateral tubal ligation, completed at least 12 weeks prior to Screening;
Exclusion criteria
. Has a history or evidence of systemic autoimmune disease;
. Has received immunoglobulin or blood products within 120 days prior to Screening;
. Has a known history or evidence of HIV infection;
. Has a known history or evidence of chronic hepatitis B defined as persistent hepatitis B surface antigen for \>6 months, or has an active hepatitis C virus (HCV) infection, defined as positive HCV RNA; Note: Patients with positive HCV antibodies and negative HCV RNA will be permitted.
. Has a positive test for drugs of abuse at Screening (both parts) or Day -1 (Part 1);
. Is participating, plans to participate during the study period, or has participated within the last 30 days prior to Screening in any other investigational study;
. Has received an investigational drug or live vaccine within 30 days or 5 half-lives of the investigational compound, whichever is longer, prior to Screening;