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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dose Escalation Safety Study of MM-10-001

Conditions
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Healthy

Intervention / Treatment
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* Other: lentinan
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects of both genders, age > 45 years old will be eligible for study. Exclusion Criteria: Subjects who: Fail to give written informed consent Have BMI over or equal to 30 kg/m2 Use corticosteroids (including inhaled steroids) or NSAIDs anti-inflammatory drugs Have uncontrolled hypertension (sitting diastolic blood pressure>95 mmHg) Have on-going allergy or history of anaphylactic reaction Have on-going allergen specific immunotherapy Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response) Have chronic inflammatory disease Have diabetes (type 1 or type 2) Have chronic severe renal disease (creatinine outside normal range) Have chronic severe liver disease (ASAT and/or ALAT more than two times the upper limit of the normal range) Have known cardiac failure Have recently (less than 6 months) experienced myocardial infarction Have gastrointestinal diseases (chronic gastritis, IBD, etc.) Have acute or chronic pancreatitis or impaired pancreatic function, or history of pancreatitis Have been vaccinated within the last three months Eat diet supplement NG24 beta-glucan Eat shiitake cheese Have systemic fungal infection Have any clinical condition that renders them unfit to participate including known/suspected drug or alcohol abuse Do not fully understand the content of the informed consent Pregnant and lactating women or women of childbearing potential not using adequate contraception.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: lentinan<br>* 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.<br>|
| Placebo Comparator: 2<br> | Other: placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood safety parameters |  | every second week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell mediated immune response and cytokine production |  | every second week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-glucan, immune system, Healthy subjects