Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 10:46 PM
Study NCT ID:
NCT00435968
Status:
COMPLETED
Last Update Posted:
2007-07-17
First Post:
2007-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
Sponsor:
CV Technologies
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: