Community-acquired PneumoniaPhase 1NCT05629741
A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
A Phase 1 study testing CMTX-101 in people with Community-acquired Pneumonia and Bacterial Pneumonia, run by Clarametyx Biosciences, Inc. at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-acquired Pneumonia, Bacterial Pneumonia
- What is being tested?
- CMTX-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Nov 2022to 2 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- Acceptable methods of contraception for male subjects include the following:
- Condoms with spermicide;
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- 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.
- Acceptable methods of contraception for female subjects include the following:
- Bilateral tubal ligation, completed at least 12 weeks prior to Screening;
- Intrauterine device used for at least 12 weeks prior to Screening;
- Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks prior to Screening;
- Diaphragm used in combination with spermicide; or
- Sexual abstinence (i.e., refraining from heterosexual intercourse), if the preferred and usual lifestyle of the subject.
- If a male subject, must agree to abstain from sperm donation through 4 months after infusion of the last dose of study drug;
- If a female of childbearing potential, must demonstrate a negative serum pregnancy test at Screening and prior to study drug administration;
- Is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the Investigator;
- Agrees to stay in contact with the site for the duration of the study and provide updated contact information as necessary;
- Agrees to avoid elective surgery for the duration of the study;
- Has known or suspected CABP requiring hospitalization with the following criteria at any time during the Screening period:
- Presents with at least 2 of the following symptoms:
- Difficulty breathing; ii. New-onset cough or worsening of baseline cough; iii. Purulent sputum production; or iv. Pleuritic chest pain due to pneumonia.
- Has at least 1 of the following vital sign abnormalities:
- Fever (oral or tympanic temperature ≥38.3°C [≥100.9°F]) or hypothermia (oral or tympanic temperature <36.0°C [<96.8°F]) within 24 hours of screening: this can be documented by the patient or a health care provider ii. Tachycardia (heart rate >100 bpm); or iii. Tachypnea (respiratory rate >20 breaths per minute).
- Has at least 1 of the following signs:
- Hypoxemia, defined as an oxygen saturation <92% room air or while receiving supplemental oxygen at the subject's baseline requirement OR a PaO2 <60 mmHg; ii. Clinical evidence of pulmonary consolidation defined as auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness); or iii. Leukocytosis, defined as a peripheral white blood cell (WBC) count >10,000/mm3, >15% immature neutrophils (bands) regardless of total WBC count, or leukopenia, defined as a total WBC count <4500 mm3.
- Has radiographic evidence of pneumonia within 48 hours before Screening (i.e., infiltrates in a lobar or multi-lobar distribution or diffuse opacities on a chest X-ray or computed tomography scan consistent with bacterial pneumonia); and
- Has pneumonia suspected or confirmed of bacterial etiology. Note: The aforementioned symptoms and signs do not have to occur simultaneously at 1 given time point to meet the criterion but must occur during the Screening period.
Who cannot join
- 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;
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- 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;
- Is currently pregnant or lactating/nursing;
- Has a history or evidence of an allergic reaction that, in the opinion of the Investigator, may compromise the safety of the subject;
- Has a known or suspected hypersensitivity to CMTX-101 or its excipients;
- Has a history or presence of an abnormal 12-lead ECG that, in the opinion of the Investigator, is clinically significant or a QTcF ≥450 milliseconds for males and ≥470 milliseconds for females at Screening (both parts) or Day -1 (Part 1); Note: the exclusion criterion should be evaluated based upon the average of the triplicate 12-lead ECG performed at Screening or Day -1 (Part 1)
- Has a history or evidence of any other acute or chronic disease that, in the opinion of the Investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject;
- Has an oral temperature ≥37.5°C (≥99.5°F) at Screening or Day -1;
- Has an abnormal WBC count, hemoglobin, or platelet count (i.e., >1.5 x upper limit of normal [ULN] or >0.5 x below the lower limit of normal (LLN) per the local laboratory or deemed to be clinically significant per the Investigator) at Screening or Day -1;
- Has an abnormally elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase (ALP), blood urea nitrogen, or creatinine (i.e., >1.5 x ULN per the local laboratory) at Screening or Day -1;
- Has an abnormal urinalysis at Screening or Day -1 that, in the opinion of the Investigator, is clinically significant;
- Is positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using a rapid antigen test at Day -1;
- Has received immunosuppressive medications within 45 days prior to Screening;
- Is unable or unwilling to stop all prescription or over-the-counter medications (other than contraceptive medications) from 14 days prior to dosing until the end of the study;
- Has hospital-acquired bacterial pneumonia, defined as pneumonia developed ≥48 hours after a hospital admission;
- Requires mechanical ventilation, defined as 1 of the following:
- Endotracheal intubation;
- Oxygen delivered by high-flow nasal cannula with flow rates >20 L/minute with an FiO2 of ≥0.5; or
- Non-invasive positive pressure ventilation.
- Has hypotension, defined as a systolic blood pressure <90 mmHg;
- Has known evidence of bone marrow suppression defined as the following:
- Leukocytes <3000 cells/µL;
- Absolute neutrophil count <1500 cells/µL;
- Platelets <100,000/µL; or
- Hemoglobin <8 g/dL.
- Has known liver function test abnormalities defined as the following:
- Total bilirubin >1.5 x ULN;
- ALT and/or AST >3 x ULN; or
- ALP >2.5 x ULN.
- Has a known estimated glomerular filtration rate <30 mL/min;
- Has received >24 hours of IV antibiotic administration during the current hospitalization for CABP; Note: Patients who have received IV standard-of-care antibiotics for >24 hours but ≤36 hours during their hospitalization may be considered for enrollment on a case-by-case basis after Medical Monitor and/or Sponsor approval.
- Note: There is no restriction on the duration of outpatient antibiotics that the patient may have received prior to hospitalization;
- Has a confirmed or suspected pleural empyema (does not include sterile parapneumonic effusion);
- Has known or suspected meningitis, endocarditis, or osteomyelitis;
- Has a history of post-obstructive pneumonia;
- Has suspected or confirmed active primary lung cancer or another malignancy metastatic to the lungs;
- Has a noninfectious cause of pulmonary infiltrates (i.e., pulmonary embolism, chemical pneumonitis, congestive heart failure, lung cancer, or cystic fibrosis);
- Has a known or suspected pneumonia of viral etiology, confirmed by a rapid viral diagnostic panel; Note: If a viral respiratory panel has not been collected within the 24 hours prior to Screening, a viral respiratory panel will be administered at Screening to determine eligibility. At a minimum, the panel will evaluate for respiratory syncytial virus, influenza A, influenza B and SARS-CoV-2.
- Has known severe immunosuppression, including but not limited to receipt of corticosteroid therapy (i.e., ≥20 mg of prednisone/day or equivalent for >4 weeks) within the previous 8 weeks, solid organ or bone marrow transplantation within the previous 12 months, or is currently receiving cytotoxic chemotherapy; or
- Has a life expectancy of ≤3 months because of any disease or has a medical, psychiatric, occupational, or substance abuse problem that, in the opinion of the Investigator, will make it unlikely that the subject will comply with the Protocol.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Augusta University Health
Augusta, Georgia, 30912
Buffalo VA Medical Center
Buffalo, New York, 14215
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
The Ohio State University
Columbus, Ohio, 43210
Wayne State University
Detroit, Michigan, 48202
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
University of Louisville
Louisville, Kentucky, 40292
About this study
Official title: A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101, an Anti-DNABII Monoclonal Antibody, in Healthy Subjects (Part 1) and Hospitalized Subjects with Suspected or Confirmed Community-Acquired Bacterial Pneumonia of Moderate Severity (Part 2)
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:
Read more
- 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.
- Conditions
- Community-acquired Pneumonia, Bacterial Pneumonia
- Being tested
- CMTX-101, Placebo
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMTX-101Drug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| CMTX-101 2.5 mg/kg | Experimental | CMTX-101 will be administered as a single IV infusion over 60 minutes. Receives: Drug: CMTX-101 |
| CMTX-101 5 mg/kg | Experimental | CMTX-101 will be administered as a single IV infusion over 60 minutes. Receives: Drug: CMTX-101 |
| CMTX-101 15 mg/kg | Experimental | CMTX-101 will be administered as a single IV infusion over 60 minutes. Receives: Drug: CMTX-101 |
| CMTX-101 30 mg/kg | Experimental | CMTX-101 will be administered as a single IV infusion over 60 minutes. Receives: Drug: CMTX-101 |
| CMTX-101 0 mg/kg | Placebo comparator | Placebo will be administered as a single IV infusion over 60 minutes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion
Primary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Number and % of healthy subjects experiencing Serious Adverse Events following ascending doses of a single CMTX-101 IV infusion
Primary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Number and % of healthy subjects experiencing Solicited Adverse Events following ascending doses of a single CMTX-101 IV infusion
Primary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
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
Primary objective of Part 2
Measured: Day 1 to Day 35
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
Primary objective of Part 2
Measured: Day 1 to Day 35
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
Primary objective of Part 2
Measured: Day 1 to Day 35
Secondary outcomes (18)
Assess the CMax - Observed maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the TMax - Time to reach maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the AUC0-last Area under the concentration time curve following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Terminal phase elimination rate determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Terminal elimination half-determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Apparent total body clearance (CL/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Apparent volume of distribution (Vz/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies (ADAs) determined by electrochemiluminescence assay following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Secondary objective of Part 1
Measured: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the CMax - Observed maximum plasma concentration determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
Assess the TMax - Time to reach maximum plasma concentration determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
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
Secondary objective of Part 2
Measured: Day 1 to Day 35
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
Secondary objective of Part 2
Measured: Day 1 to Day 35
Assess the Terminal phase elimination rate determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
Assess the Terminal elimination half-determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
Assess the Apparent total body clearance (CL/F) determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
Assess the Apparent volume of distribution (Vz/F) determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies determined by electrochemiluminescence assay following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Secondary objective of Part 2
Measured: Day 1 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start14 Nov 2022
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarametyx Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629741
- Sponsor's protocol ID
- CMTX101-P1-CT001
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101, an Anti-DNABII Monoclonal Antibody, in Healthy Subjects (Part 1) and Hospitalized Subjects with Suspected or Confirmed Community-Acquired Bacterial Pneumonia of Moderate Severity (Part 2)
- ClinicalTrials.gov ID
- NCT05629741
- Acronym / sponsor ID
- CMTX101-P1-CT001
- Conditions
- Community-acquired Pneumonia, Bacterial Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Clarametyx Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CMTX-101 2.5 mg/kg | Experimental | Drug: CMTX-101CMTX-101 will be administered as a single IV infusion over 60 minutes. |
| CMTX-101 5 mg/kg | Experimental | Drug: CMTX-101CMTX-101 will be administered as a single IV infusion over 60 minutes. |
| CMTX-101 15 mg/kg | Experimental | Drug: CMTX-101CMTX-101 will be administered as a single IV infusion over 60 minutes. |
| CMTX-101 30 mg/kg | Experimental | Drug: CMTX-101CMTX-101 will be administered as a single IV infusion over 60 minutes. |
| CMTX-101 0 mg/kg | Placebo comparator | Drug: PlaceboPlacebo will be administered as a single IV infusion over 60 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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;
- If a male subject, must agree to abstain from sperm donation through 4 months after infusion of the last dose of study drug;
Key exclusion criteria (45 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMTX-101Administered as specified in the treatment arm | Drug | CMTX-101 15 mg/kg, CMTX-101 2.5 mg/kg, CMTX-101 30 mg/kg, CMTX-101 5 mg/kg |
| PlaceboAdministered as specified in the treatment arm | Drug | CMTX-101 0 mg/kg |
Primary outcome
Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Primary objective of Part 1
Number and % of healthy subjects experiencing Serious Adverse Events following ascending doses of a single CMTX-101 IV infusion
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Primary objective of Part 1
Number and % of healthy subjects experiencing Solicited Adverse Events following ascending doses of a single CMTX-101 IV infusion
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Primary objective of Part 1
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
Time frame: Day 1 to Day 35
Primary objective of Part 2
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
Time frame: Day 1 to Day 35
Primary objective of Part 2
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
Time frame: Day 1 to Day 35
Primary objective of Part 2
18 secondary outcomes
Assess the CMax - Observed maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the TMax - Time to reach maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the AUC0-last Area under the concentration time curve following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Terminal phase elimination rate determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Terminal elimination half-determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Apparent total body clearance (CL/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the Apparent volume of distribution (Vz/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies (ADAs) determined by electrochemiluminescence assay following ascending doses of a single CMTX-101 IV infusion in healthy subjects
Time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Assess the CMax - Observed maximum plasma concentration determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
Assess the TMax - Time to reach maximum plasma concentration determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
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
Time frame: Day 1 to Day 35
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
Time frame: Day 1 to Day 35
Assess the Terminal phase elimination rate determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
Assess the Terminal elimination half-determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
Assess the Apparent total body clearance (CL/F) determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
Assess the Apparent volume of distribution (Vz/F) determined by ELISA following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies determined by electrochemiluminescence assay following a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity
Time frame: Day 1 to Day 35
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMTX-101 in people with Community-acquired Pneumonia and Bacterial Pneumonia, run by Clarametyx Biosciences, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion (time frame: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.