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

Healthy Clinical Trial

Official title:

Dose Escalation Safety Study of MM-10-001

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00677027
• Other study ID #: 1.2006.3622 (REK)
• Secondary ID: 07/02312 (SLV)
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 9, 2008
• Last updated: May 12, 2008
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: May 2008
• Source: GlycaNova Norge AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Norwegian Institute of Public HealthNorway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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.
• placebo
Placebo

Locations

Country	Name	City	State
Norway	Centre for clinical studies	Bergen	Paradis

Sponsors (2)

Lead Sponsor	Collaborator
GlycaNova Norge AS	Centre for clinical studies, Bergen, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood safety parameters		every second week	Yes
Secondary	Cell mediated immune response and cytokine production		every second week	Yes