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

Phase 1

• Conditions: Healthy
• Interventions: Other: lentinan; Other: placebo

• Registration Number: NCT00677027
• Lead Sponsor: GlycaNova Norge AS

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.

Study Timeline

• Study Start: 2008-02
• Status Verified: 2008-05
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-12
• Last Update Submitted: 2008-05-12
• Study First Posted: 2008-05-13
• Last Update Posted: 2008-05-13
• Primary Completion: 2008-06
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	lentinan	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Blood safety parameters	every second week

Secondary Outcome Measures

Name	Time	Method
Cell mediated immune response and cytokine production	every second week

Trial Locations

Locations (1)

Centre for clinical studies; 🇳🇴 Bergen, Paradis, Norway