Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 6:51 PM
Study NCT ID:
NCT01338935
Status:
TERMINATED
Last Update Posted:
2014-02-04
First Post:
2011-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of CW002
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
A Phase I, Single-Site, Tri-Institutional, Open-Label, Three-Part, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of CW002 in Healthy Adult Anesthetized Volunteers
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pharmacokinetic stopping criteria for the study were met.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CW002
Brief Summary:
The purpose of this study is to test the safety and efficacy of an investigational neuromuscular blocking agent called CW002 and to document its effects on healthy adult volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from moving. CW002 has not yet been approved by the Food and Drug Administration (FDA).
Usually, neuromuscular blocking agents are used together with other drugs that put people completely "asleep". These drugs allow doctors to place a breathing tube in the airway, stop muscles from moving during surgical operations, and allow ventilation (movement of air).
This research is being done because CW002 is expected to act quickly and to provide a muscle block of intermediate (not too long, not too short) duration. The researchers would like to test increasing doses of CW002 that can be given without causing severe side effects. If shown to be both safe and effective, such a compound would be useful in surgical procedures and could improve future anesthetic care.
Usually, neuromuscular blocking agents are used together with other drugs that put people completely "asleep". These drugs allow doctors to place a breathing tube in the airway, stop muscles from moving during surgical operations, and allow ventilation (movement of air).
This research is being done because CW002 is expected to act quickly and to provide a muscle block of intermediate (not too long, not too short) duration. The researchers would like to test increasing doses of CW002 that can be given without causing severe side effects. If shown to be both safe and effective, such a compound would be useful in surgical procedures and could improve future anesthetic care.
Detailed Description:
Neuromuscular blocking agents are especially important in intubation (insertion of breathing tube into the windpipe) because a quick and effective muscle block is needed to promptly complete the process and secure the airway. In addition, being able to rapidly reverse a blocking agent is desirable so that the patient can breathe on his/her own as soon as possible.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: