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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by GlycaNova Norge AS.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centre for clinical studies, Bergen, Norway
Information provided by:
GlycaNova Norge AS
ClinicalTrials.gov Identifier:
NCT00677027
First received: May 9, 2008
Last updated: May 12, 2008
Last verified: May 2008
  Purpose

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
Healthy
Other: lentinan
Other: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cell mediated immune response and cytokine production [ Time Frame: every second week ] [ Designated as safety issue: Yes ]

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
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677027

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

No publications provided

Responsible Party: Tor Albrektsen, GlycaNova Norge AS
ClinicalTrials.gov 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
Health Authority: Norway: Directorate of Health
Norway: Norwegian Institute of Public Health
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by GlycaNova Norge AS:
Beta-glucan
immune system
Healthy subjects

ClinicalTrials.gov processed this record on September 30, 2014