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)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CMTX-101 2.5 mg/kg
CMTX-101 will be administered as a single IV infusion over 60 minutes.
干预措施: CMTX-101 (Drug)
CMTX-101 5 mg/kg
CMTX-101 will be administered as a single IV infusion over 60 minutes.
干预措施: CMTX-101 (Drug)
CMTX-101 15 mg/kg
CMTX-101 will be administered as a single IV infusion over 60 minutes.
干预措施: CMTX-101 (Drug)
CMTX-101 30 mg/kg
CMTX-101 will be administered as a single IV infusion over 60 minutes.
干预措施: CMTX-101 (Drug)
CMTX-101 0 mg/kg
Placebo will be administered as a single IV infusion over 60 minutes
干预措施: Placebo (Drug)
结局指标
主要结局
Number and % of healthy subjects experiencing Adverse Events following ascending doses of a single CMTX-101 IV infusion
时间窗: 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 Serious Adverse Events following dosing of a single CMTX-101 IV infusion
时间窗: 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
时间窗: Day 1 to Day 35
Primary objective of Part 2
Number and % of healthy subjects experiencing Serious Adverse Events following ascending doses of a single CMTX-101 IV infusion
时间窗: 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
时间窗: Day 1 to Day 35
Primary objective of Part 2
Number and % of healthy subjects experiencing Solicited Adverse Events following ascending doses of a single CMTX-101 IV infusion
时间窗: Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.
Primary objective of Part 1
次要结局
- Assess the AUC0-last Area under the concentration time curve following ascending doses of a single CMTX-101 IV infusion in healthy subjects(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(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(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 a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity(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(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(Day 1 to Day 35)
- 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(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(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(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(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(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(Day 1 to Day 35)
- Assess the Apparent total body clearance (CL/F) determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects(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 a single dose of a CMTX-101 IV infusion in hospitalized subjects with suspected or confirmed CABP of moderate severity(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(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(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(Day 1 to Day 35)
- Assess the CMax - Observed maximum plasma concentration determined by ELISA following ascending doses of a single CMTX-101 IV infusion in healthy subjects(Cohorts 1 and 2: Day 1 to Day 29. Cohorts 3 and 4: Day 1 to Day 100.)