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Status unknownNCT00677027Updated May 13, 2008

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

A Phase 1 interventional study of lentinan and placebo in Healthy, sponsored by GlycaNova Norge AS. Status unknown at 1 site in Norway. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-13.

Sponsored by GlycaNova Norge AS · Phase 1, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Beta-glucan
  • immune system
  • Healthy subjects
03

In context

Lead sponsor

This is the only study on the registry with GlycaNova Norge AS as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy subjects of both genders, age > 45 years old will be eligible for study.

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    1

    Other: lentinan

  • Placebo comparator
    2

    Other: placebo

Interventions

  • Otherlentinan

    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.

  • Otherplacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Blood safety parameters

    Time frame: every second week

Secondary outcomes

  1. Cell mediated immune response and cytokine production

    Time frame: every second week

07

Study locations

1 site
  • Centre for clinical studies
    Bergen, Paradis 5231, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00677027
Lead sponsor
GlycaNova Norge AS
Collaborators
Centre for clinical studies, Bergen, Norway
First posted
May 13, 2008
Start date
Feb 2008
Primary completion
Jun 2008 (estimated)
Completion
Jun 2008 (estimated)
Last update
May 13, 2008

Study contacts

Snorre Ofjord, MD
principal investigator · Centre for clinical studies, Bergen, Norway

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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