Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05629741
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2022-11-09
Brief Title:
A 2-Part First-in-Human Study to Evaluate the Safety Tolerability Pharmacokinetics and Immunogenicity of CMTX-101
Sponsor:
Clarametyx Biosciences Inc
Organization:
Clarametyx Biosciences Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None