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Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of CW002 — CW002  

Healthy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01338935
Study type Interventional
Source Weill Medical College of Cornell University
Contact
Status Terminated
Phase Phase 1
Start date May 2011
Completion date November 2013
View Details
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