NCT00435968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 17, 2007

Status Verified

July 1, 2007

First QC Date

February 14, 2007

Last Update Submit

July 16, 2007

Conditions

Healthy

Keywords

NK CellsCytokinesLymphocytesImmunoglobulinsTh1 response

Outcome Measures

Primary Outcomes (1)

  • The change in innate and Th1 immune responses of the subjects

Secondary Outcomes (3)

  • Proportions of different leukocytes and lymphocytes in blood

  • Intracellular and plasma concentrations of various cytokines and immunoglobulins

  • Incidence and severity of adverse events

Interventions

CVT E002 (Cold-fX)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General good health
  • Willing to adhere to the requirements of the protocol, including availability for follow-up visits
  • Willing and able to sign written informed consent

You may not qualify if:

  • Individuals with known HIV infection
  • Individuals with malignancy
  • Individuals with a history or symptoms of unstable cardiovascular disease
  • Individuals with renal abnormalities
  • Individuals having a history or symptoms of pulmonary disease
  • Individuals having acute or active chronic liver disease
  • Individuals having neurologic or psychiatric disease
  • Individuals having active tuberculosis
  • Individuals having multiple sclerosis
  • Individuals having bleeding disorders
  • Individuals with planned surgery over the course of the trial or having had major surgery in the past 6 mo.
  • Individuals with a history of alcohol/drug abuse
  • Pregnant and lactating women
  • Individuals on prescribed medication with the exception of oral contraceptives
  • Individuals with Crohn's disease, Lupus, Rheumatoid arthritis, Colitis or any other auto-immune disease
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

COLD-fX

Study Officials

  • Steven Sperber, MD

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 16, 2007

Study Start

March 1, 2007

Study Completion

July 1, 2007

Last Updated

July 17, 2007

Record last verified: 2007-07

Locations

US(1)