Dose Escalation Safety Study of MM-10-001 in Healthy Subj... | NCT00677027

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

NCT00677027

Sponsor

GlycaNova Norge AS

Status

Unknown status

Last Update Posted

May 13, 2008Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

lentinan
placebo

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
07/02312 (SLV)

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jun 2008Estimated

Completion Date

Jun 2008Estimated

First Submitted Date

May 9, 2008

First Submission Date that Met QC Criteria

May 12, 2008

First Posted Date

May 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2008

Last Update Posted Date

May 13, 2008Estimated

Name	Class
Centre for clinical studies, Bergen, Norway	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Other: lentinan
2	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lentinan	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.

Measure	Description	Time Frame
Blood safety parameters		every second week

Measure	Description	Time Frame
Cell mediated immune response and cytokine production		every second week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.)
Have acute or chronic pancreatitis or impaired pancreatic function, or history of pancreatitis
Have been vaccinated within the last three months
Eat diet supplement NG24 beta-glucan
Eat shiitake cheese
Have systemic fungal infection
Have any clinical condition that renders them unfit to participate including known/suspected drug or alcohol abuse
Do not fully understand the content of the informed consent
Pregnant and lactating women or women of childbearing potential not using adequate contraception.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D047071	beta-Glucans
D005936	Glucans
D011134	Polysaccharides
D002241	Carbohydrates