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CoFactor

Phase 1

Healthy Adults | Small molecule | Other |Savara, Inc.|Last Updated: May 28, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

CoFactor · 1 trial · 1 indication

Phase 1 1
NCT00663481A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.Healthy Adults
COMPLETED15 Analytics
PHASE1COMPLETED
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Healthy Adults
NCT0066348115
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Study Endpoints

Primary Endpoints

Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.

Secondary Endpoints

To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCoFactor
2EXPERIMENTALCoFactor
3ACTIVE_COMPARATORLeucovorin

Interventions

NameTypeDescription
CoFactorDRUG -
LeucovorinDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 9...

Countries:United States
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Frequently asked questions about CoFactor

What is CoFactor used for?

CoFactor is an investigational small molecule being studied for use in colon cancer and rectal cancer, specifically in patients with metastatic colorectal cancer. It has also been evaluated in healthy adult subjects in early-stage clinical trials. CoFactor is not approved and remains in clinical development.

Who makes CoFactor?

CoFactor is being developed by Savara, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVRA. The company has sponsored clinical trials of CoFactor in metastatic colorectal cancer and in healthy adult subjects.

What phase is CoFactor in?

CoFactor is in Phase 1 clinical development. While two completed trials of CoFactor in metastatic colorectal cancer were Phase 2 studies, the most recent trial, which evaluated CoFactor formulations in healthy adults, was a Phase 1 study. CoFactor is investigational and not FDA approved.

What clinical trials is CoFactor in?

CoFactor has been studied in three completed clinical trials. NCT00081627 and NCT00235898 were Phase 2 trials in patients with metastatic colorectal cancer, enrolling 48 and 300 patients respectively. NCT00663481 was a Phase 1 trial in healthy adults with 15 participants. All trials are completed.

How does CoFactor work?

CoFactor is a small molecule therapeutic being investigated for the treatment of metastatic colorectal cancer. Its specific molecular target has not been disclosed in available clinical trial information. The drug has been studied in active-controlled trials, but its mechanism of action is not publicly detailed.