HealthyPhase 1NCT00677027
Dose Escalation Safety Study of MM-10-001 in Healthy Subjects
A Phase 1 study testing lentinan in people with Healthy, run by GlycaNova Norge AS at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- lentinan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2008to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects of both genders, age > 45 years old will be eligible for study.
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalation Safety Study of MM-10-001
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.
- Conditions
- Healthy
- Being tested
- lentinan, placebo
- Keywords
- Beta-glucan, immune system, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
placeboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: lentinan |
| 2 | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood safety parameters
Measured: every second week
Secondary outcomes (1)
Cell mediated immune response and cytokine production
Measured: every second week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlycaNova Norge AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for clinical studies, Bergen, Norway
- Investigators
- Snorre Ofjord, MD, Principal investigator, Centre for clinical studies, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677027
- Sponsor's protocol ID
- 1.2006.3622 (REK)
- Other IDs
- 07/02312 (SLV)
- Status last verified
- May 2008
- First submitted
- 9 May 2008
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Safety Study of MM-10-001
- ClinicalTrials.gov ID
- NCT00677027
- Acronym / sponsor ID
- 1.2006.3622 (REK)
- Conditions
- Healthy
- Keywords
- Beta-glucan, immune system, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GlycaNova Norge ASIndustry (pharma, biotech, devices)
- Collaborators
- Centre for clinical studies, Bergen, Norway
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: lentinan |
| 2 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects of both genders, age > 45 years old will be eligible for study.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lentinanFive 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. | Other | 1 |
| placeboPlacebo | Other | 2 |
Primary outcome
Blood safety parameters
Time frame: every second week
1 secondary outcome
Cell mediated immune response and cytokine production
Time frame: every second week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snorre Ofjord, MD principal investigator
Centre for clinical studies, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lentinan in people with Healthy, run by GlycaNova Norge AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood safety parameters (time frame: every second week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2008.