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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by GlycaNova Norge AS.
Recruitment status was:  Active, not recruiting
Centre for clinical studies, Bergen, Norway
Information provided by:
GlycaNova Norge AS Identifier:
First received: May 9, 2008
Last updated: May 12, 2008
Last verified: May 2008
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.

Condition Intervention Phase
Other: lentinan
Other: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Dose Escalation Safety Study of MM-10-001

Further study details as provided by GlycaNova Norge AS:

Primary Outcome Measures:
  • Blood safety parameters [ Time Frame: every second week ]

Secondary Outcome Measures:
  • Cell mediated immune response and cytokine production [ Time Frame: every second week ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00677027

Centre for clinical studies
Bergen, Paradis, Norway, 5231
Sponsors and Collaborators
GlycaNova Norge AS
Centre for clinical studies, Bergen, Norway
Principal Investigator: Snorre Ofjord, MD Centre for clinical studies, Bergen, Norway
  More Information

Responsible Party: Tor Albrektsen, GlycaNova Norge AS Identifier: NCT00677027     History of Changes
Other Study ID Numbers: 1.2006.3622 (REK)
07/02312 (SLV)
Study First Received: May 9, 2008
Last Updated: May 12, 2008

Keywords provided by GlycaNova Norge AS:
immune system
Healthy subjects

Additional relevant MeSH terms:
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents processed this record on April 26, 2017