Status:
UNKNOWN
Dose Escalation Safety Study of MM-10-001 in Healthy Subjects
Lead Sponsor:
GlycaNova Norge AS
Collaborating Sponsors:
Centre for clinical studies, Bergen, Norway
Conditions:
Healthy
Eligibility:
All Genders
45+ years
Phase:
PHASE1
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 deter...
Eligibility Criteria
Inclusion
- Healthy subjects of both genders, age \> 45 years old will be eligible for study.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00677027
Start Date
February 1 2008
End Date
June 1 2008
Last Update
May 13 2008
Active Locations (1)
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1
Centre for clinical studies
Bergen, Paradis, Norway, 5231