A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

Genaera Corporation1 site in 1 country42 target enrollmentMay 2007

ConditionsObesity

Drugstrodusquemine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Obesity
Sponsor: Genaera Corporation
Enrollment: 42
Locations: 1
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. Finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

October 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genaera Corporation

Eligibility Criteria

Inclusion Criteria

•male or female subjects, between 18 and 55 years old (inclusive);
•body mass index (BMI) of 27-40 kg/m2;

Exclusion Criteria

•likely allergy or sensitivity to any components of Trodusquemine for Injection based on known allergies to drugs of the same class, or which, in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine HCl;
•any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
•any subject with a history of severe allergy or bronchial asthma;