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

NCT ID: NCT00677027

Last Updated: 2008-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-06-30

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.

Conditions

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Healthy

Keywords

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Beta-glucan immune system Healthy subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

lentinan

Intervention Type OTHER

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.

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Placebo

Interventions

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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.

Intervention Type OTHER

placebo

Placebo

Intervention Type OTHER

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:

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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for clinical studies, Bergen, Norway

UNKNOWN

Sponsor Role collaborator

GlycaNova Norge AS

INDUSTRY

Sponsor Role lead

Responsible Party

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GlycaNova Norge AS

Principal Investigators

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Snorre Ofjord, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for clinical studies, Bergen, Norway

Locations

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Centre for clinical studies

Bergen, Paradis, Norway

Site Status

Countries

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Norway

Other Identifiers

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07/02312 (SLV)

Identifier Type: -

Identifier Source: secondary_id

1.2006.3622 (REK)

Identifier Type: -

Identifier Source: org_study_id