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

GlycaNova

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Other: lentinan; Other: placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00677027

07/02312 (SLV)

1.2006.3622 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Other: lentinan

2

Placebo Comparator group

Treatment:

Other: placebo