Dose Escalation Safety Study of MM-10-001 in Healthy Subjects

May 12, 2008 updated by: GlycaNova Norge AS

Dose Escalation Safety Study of MM-10-001

The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The drug substance to be studied is a powder produced from shiitake mushroom, containing beta-glucans. The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Paradis
      • Bergen, Paradis, Norway, 5231
        • Centre for Clinical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy subjects of both genders, age > 45 years old will be eligible for study.

Exclusion Criteria:

Subjects who:

  1. Fail to give written informed consent
  2. Have BMI over or equal to 30 kg/m2
  3. Use corticosteroids (including inhaled steroids) or NSAIDs anti-inflammatory drugs
  4. Have uncontrolled hypertension (sitting diastolic blood pressure>95 mmHg)
  5. Have on-going allergy or history of anaphylactic reaction
  6. Have on-going allergen specific immunotherapy
  7. Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
  8. Have chronic inflammatory disease
  9. Have diabetes (type 1 or type 2)
  10. Have chronic severe renal disease (creatinine outside normal range)
  11. Have chronic severe liver disease (ASAT and/or ALAT more than two times the upper limit of the normal range)
  12. Have known cardiac failure
  13. Have recently (less than 6 months) experienced myocardial infarction
  14. Have gastrointestinal diseases (chronic gastritis, IBD, etc.)
  15. Have acute or chronic pancreatitis or impaired pancreatic function, or history of pancreatitis
  16. Have been vaccinated within the last three months
  17. Eat diet supplement NG24 beta-glucan
  18. Eat shiitake cheese
  19. Have systemic fungal infection
  20. Have any clinical condition that renders them unfit to participate including known/suspected drug or alcohol abuse
  21. Do not fully understand the content of the informed consent
  22. Pregnant and lactating women or women of childbearing potential not using adequate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Other: lentinan
Five dose levels of escalating concentrations of the test substance will be tested during the study periode. All patients will recieve each dose, which is to be taken daily for two weeks.
Placebo Comparator: 2
Other: placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood safety parameters
Time Frame: every second week
every second week

Secondary Outcome Measures

Outcome Measure
Time Frame
Cell mediated immune response and cytokine production
Time Frame: every second week
every second week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlycaNova Norge AS

Collaborators

Centre for clinical studies, Bergen, Norway

Investigators

  • Principal Investigator: Snorre Ofjord, MD, Centre for clinical studies, Bergen, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

June 1, 2008

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2008

Last Update Submitted That Met QC Criteria

May 12, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2006.3622 (REK)
  • 07/02312 (SLV)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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