Dose Escalation Safety Study of MM-10-001 in Healthy Subjects
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by GlycaNova Norge AS.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
GlycaNova Norge AS
Collaborator:
Centre for clinical studies, Bergen, Norway
Information provided by:
GlycaNova Norge AS
ClinicalTrials.gov Identifier:
NCT00677027
First received: May 9, 2008
Last updated: May 12, 2008
Last verified: May 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Other: lentinan Other: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Dose Escalation Safety Study of MM-10-001 |
Further study details as provided by GlycaNova Norge AS:
Primary Outcome Measures:
- Blood safety parameters [ Time Frame: every second week ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cell mediated immune response and cytokine production [ Time Frame: every second week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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 Comparator: 2 |
Other: placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677027
Locations
| Norway | |
| Centre for clinical studies | |
| Bergen, Paradis, Norway, 5231 | |
Sponsors and Collaborators
GlycaNova Norge AS
Centre for clinical studies, Bergen, Norway
Investigators
| Principal Investigator: | Snorre Ofjord, MD | Centre for clinical studies, Bergen, Norway |
More Information
No publications provided
| Responsible Party: | Tor Albrektsen, GlycaNova Norge AS |
| ClinicalTrials.gov Identifier: | NCT00677027 History of Changes |
| Other Study ID Numbers: | 1.2006.3622 (REK), 07/02312 (SLV) |
| Study First Received: | May 9, 2008 |
| Last Updated: | May 12, 2008 |
| Health Authority: | Norway: Directorate of Health Norway: Norwegian Institute of Public Health Norway: Norwegian Medicines Agency Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by GlycaNova Norge AS:
|
Beta-glucan immune system Healthy subjects |
Additional relevant MeSH terms:
|
Lentinan Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013