Overview

This trial is active, not recruiting.

Condition healthy
Treatments lentinan, placebo
Phase phase 1
Sponsor GlycaNova Norge AS
Collaborator Centre for clinical studies, Bergen, Norway
Start date February 2008
End date June 2008
Trial size 50 participants
Trial identifier NCT00677027, 07/02312 (SLV), 1.2006.3622 (REK)

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose supportive care
Arm
(Experimental)
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)
placebo
Placebo

Primary Outcomes

Measure
Blood safety parameters
time frame: every second week

Secondary Outcomes

Measure
Cell mediated immune response and cytokine production
time frame: every second week

Eligibility Criteria

Male or female participants at least 45 years old.

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.

Additional Information

Official title Dose Escalation Safety Study of MM-10-001
Principal investigator Snorre Ofjord, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by GlycaNova Norge AS.