A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

Genaera

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Drug: trodusquemine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00509132

MSI-1436C-101

Details and patient eligibility

About

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).

Enrollment

42 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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;