Healthy
Conditions
Keywords
Beta-glucan, immune system, Healthy subjects
Brief 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.
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.
Interventions
OTHERlentinan
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.
OTHERplacebo
Placebo
Sponsors
Centre for clinical studies, Bergen, Norway
GlycaNova Norge AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood safety parameters | every second week |
Secondary
| Measure | Time frame |
|---|---|
| Cell mediated immune response and cytokine production | every second week |
Countries
Norway
Outcome results
None listed