Status:
COMPLETED
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Lead Sponsor:
Mast Therapeutics, Inc.
Conditions:
Healthy Adults
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
Eligibility Criteria
Inclusion
- Males and Females age 18-65 inclusive at screening.
- Subject has to agree to practice abstinence or medically accepted contraception and not to participate in sperm donation or in vitro fertilization.
- Body Mass Index in the range of 18 to 30 kg/m2 and body weight of 45 to 95 kg.
- Subject must be healthy as determined by the investigator on the basis of screening evaluations.
- Subject must be nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the in-clinic stay.
Exclusion
- Presence of clinically significant illness within 21 days prior to dosing, viral or bacterial infection, or documented drug allergies that may affect subject's safety during the study.
- Laboratory or clinical evidence suggestive of disease.
- Clinically significant or predisposing disorder that may interfere with the absorption, distribution, metabolism and/or excretion of drugs.
- History of drug abuse within 1 year of dosing and/or admitted alcohol abuse or history of alcohol use that may interfere with the ability to comply.
- Pregnant, lactating, or positive pregnancy test.
- Clinically significant electrocardiogram abnormalities.
- History of positive test for hepatitis B or C, or HIV.
- Positive findings of urine narcotic screen.
- History of drug allergy.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00663481
Start Date
April 1 2008
End Date
May 1 2008
Last Update
May 28 2009
Active Locations (1)
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1
Parexel International - Baltimore CPRU
Baltimore, Maryland, United States, 21225