Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435968
Status:
COMPLETED
Last Update Posted:
2007-07-17
First Post:
2007-02-14
Brief Title:
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
Sponsor:
CV Technologies
Organization:
Afexa Life Sciences Inc
Study Overview
Official Title:
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects will be asked to participate in a four day research study of the immune system effects and safety of short-term acute dosing of Cold-fX
The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo dummy pill Safety of the acute dosing will be determined through various blood tests carried out during the study
The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo dummy pill Safety of the acute dosing will be determined through various blood tests carried out during the study
Detailed Description:
Eligible volunteers from Hackensack University Medical Centre will be randomly assigned to either the treatment or placebo group with equal numbers in each group
The treatment will consist of taking three capsules of CVT-E002 600mg or placebo three times daily on Day 1 two capsules of CVT-E002 400mg or placebo three times daily on Day 2 and one capsule of CVT-E002 200mg or placebo three times daily on Day 3
A fasting blood sample will be collected on all 4 days of study participation Immunological assays and blood chemisty safety tests will be performed on the samples Serum samples will also be collected and stored until futher analysis for various cytokines
Any adverse events experienced during this study will be documented
The treatment will consist of taking three capsules of CVT-E002 600mg or placebo three times daily on Day 1 two capsules of CVT-E002 400mg or placebo three times daily on Day 2 and one capsule of CVT-E002 200mg or placebo three times daily on Day 3
A fasting blood sample will be collected on all 4 days of study participation Immunological assays and blood chemisty safety tests will be performed on the samples Serum samples will also be collected and stored until futher analysis for various cytokines
Any adverse events experienced during this study will be documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None