NCT00677027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 13, 2008

Status Verified

May 1, 2008

Enrollment Period

4 months

First QC Date

May 9, 2008

Last Update Submit

May 12, 2008

Conditions

Healthy

Keywords

Beta-glucanimmune systemHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Blood safety parameters

    every second week

Secondary Outcomes (1)

  • Cell mediated immune response and cytokine production

    every second week

Study Arms (2)

1

EXPERIMENTAL
Other: lentinan

2

PLACEBO COMPARATOR
Other: placebo

Interventions

lentinanOTHER

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.

1
placeboOTHER

Placebo

2

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects who:
  • Fail to give written informed consent
  • Have BMI over or equal to 30 kg/m2
  • Use corticosteroids (including inhaled steroids) or NSAIDs anti-inflammatory drugs
  • Have uncontrolled hypertension (sitting diastolic blood pressure\>95 mmHg)
  • Have on-going allergy or history of anaphylactic reaction
  • Have on-going allergen specific immunotherapy
  • Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
  • Have chronic inflammatory disease
  • Have diabetes (type 1 or type 2)
  • Have chronic severe renal disease (creatinine outside normal range)
  • Have chronic severe liver disease (ASAT and/or ALAT more than two times the upper limit of the normal range)
  • Have known cardiac failure
  • Have recently (less than 6 months) experienced myocardial infarction
  • Have gastrointestinal diseases (chronic gastritis, IBD, etc.)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for clinical studies

Bergen, Paradis, 5231, Norway

Location

MeSH Terms

Interventions

Lentinan

Intervention Hierarchy (Ancestors)

beta-GlucansGlucansPolysaccharidesCarbohydrates

Study Officials

  • Snorre Ofjord, MD

    Centre for clinical studies, Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 13, 2008

Record last verified: 2008-05

Locations

NO(1)