HealthyPhase 1NCT00906438
Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects
A Phase 1 study testing 2006-RD-05 in people with Healthy, run by innoVactiv Inc. at 1 site in Canada.
Trial summary
It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2006-RD-05
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Oct 2009
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 18 - 60
- In good health
- BMI between 20 and 30 kg/m2
- Non-smoking
Who cannot join
- Allergic to study drug
- Use of immune-modulating drugs
- Uncontrolled hypertension (Systolic > 140 or diastolic > 90)
- Women of childbearing age not using proper contraception, that is pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Québec, Quebec, G1K 7P4
About this study
Official title: Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects
It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.
- Conditions
- Healthy
- Being tested
- 2006-RD-05, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2006-RD-05Dietary supplement
300 mg daily, once a day for 28 consecutive days
PlaceboDietary supplement
Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Treated | Experimental | Not described Receives: Dietary Supplement: 2006-RD-05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: Baseline, 14 days, 28 days
Secondary outcomes (2)
Serum IgA titers
Measured: Baseline, 14 days, 28 days
Salivary IgA titers
Measured: Baseline, 14 days, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2009
- Study completionOct 2009
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- innoVactiv Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906438
- Sponsor's protocol ID
- 2006-RD-05-CLN1
- Status last verified
- Oct 2009
- First submitted
- 20 May 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00906438
- Acronym / sponsor ID
- 2006-RD-05-CLN1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- innoVactiv Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 May 2009 (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.
It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebo |
| Treated | Experimental | Dietary Supplement: 2006-RD-05 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men or women aged 18 - 60
- In good health
- BMI between 20 and 30 kg/m2
- Non-smoking
Key exclusion criteria (4 listed)
- Allergic to study drug
- Use of immune-modulating drugs
- Uncontrolled hypertension (Systolic > 140 or diastolic > 90)
- Women of childbearing age not using proper contraception, that is pregnant or breastfeeding
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 |
|---|---|---|
| 2006-RD-05300 mg daily, once a day for 28 consecutive days | Dietary supplement | Treated |
| PlaceboCapsule similar in shape, weight and color from active, once a day for 28 consecutive days | Dietary supplement | Control |
Primary outcome
Occurrence of adverse events
Time frame: Baseline, 14 days, 28 days
2 secondary outcomes
Serum IgA titers
Time frame: Baseline, 14 days, 28 days
Salivary IgA titers
Time frame: Baseline, 14 days, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 2006-RD-05 in people with Healthy, run by innoVactiv Inc. at 1 site in Canada.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Oct 2009. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of adverse events (time frame: Baseline, 14 days, 28 days). 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 29 Oct 2009.