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A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.

NCT ID: NCT00663481

Last Updated: 2009-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.

Detailed Description

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Conditions

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Healthy Adults

Keywords

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CoFactor ANX-510

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

CoFactor

Group Type EXPERIMENTAL

CoFactor

Intervention Type DRUG

2

CoFactor

Group Type EXPERIMENTAL

CoFactor

Intervention Type DRUG

3

Leucovorin

Group Type ACTIVE_COMPARATOR

Leucovorin

Intervention Type DRUG

Interventions

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CoFactor

Intervention Type DRUG

Leucovorin

Intervention Type DRUG

Other Intervention Names

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ANX-510

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mast Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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ADVENTRX Pharmaceuticals, Inc.

Principal Investigators

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Ronald Goldwater, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel International - Baltimore CPRU

Locations

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Parexel International - Baltimore CPRU

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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CoFactor 510-20

Identifier Type: -

Identifier Source: org_study_id