Type I HypersensitivityPhase 1NCT00109759
Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)
A Phase 1 study testing RagweedMATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Canada.
Trial summary
The safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL) was planned to be evaluated. For this purpose, a total of 4 injections of either increasing doses of the study drug or placebo (tyrosine) was planned to be administered in 7-day intervals to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type I Hypersensitivity
- What is being tested?
- RagweedMATAMPL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Jun 2005
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker and not using any nicotine products
- Negative skin prick test with a standard panel of marker allergen extracts (including ragweed allergen extract)
- Specific IgE for ragweed with class = 0
- No clinical history of IgE-mediated allergic diseases
- Subject agrees not to use any medication or herbal products during the study
- Males or non-pregnant, non-lactating females who are post-menopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study.
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- Subjects who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination, routine laboratory tests and an infection screen
- Subjects must be willing and able to attend required study visits.
- Subjects must be able to follow instructions.
Who cannot join
- Clinical history or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
- Clinical history or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders.
- Any clinically significant (as determined by the Investigator) abnormal laboratory value at Visit 1
- Clinical history of auto-immune diseases or rheumatoid diseases.
- Contraindication to adrenaline
- History of asthma
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- Subject has used any prescription medications within 14 days or over-the-counter medications, including herbal products, within 2 days prior to Screening or will likely use any medication(s) or listed product(s) during the study.
- Subject has disorder of tyrosine metabolism
- Subject with diseases with a pathogenesis interfering with the immune response and who has received medication which could influence the results of this study
- Subject has acute or chronic infection
- Clinical history of anaphylaxis
- Clinical history of angioedema
- Clinical history of hypersensitivity to the excipients of the study medication
- History of immunotherapy with ragweed allergen extracts
- Current therapy with ß-blockers
- Currently receiving anti-allergy medication or other drugs with an antihistaminic activity
- Subject has a positive screen for cotinine or drugs of abuse at Visit 1
- Subject has a positive saliva alcohol test at Visit 1
- Subject participated in a clinical trial with a new chemical substance within the last 12 months
- Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
- Subject is pregnant or lactating
- Clinically relevant abnormal vital signs or respiratory rate at the Screening Visit
- Subject received treatment with a preparation containing MPL® during the past 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Phase I Study to Evaluate the Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL® in Healthy Volunteers.
The safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL) was planned to be evaluated. For this purpose, a total of 4 injections of either increasing doses of the study drug or placebo (tyrosine) was planned to be administered in 7-day intervals to healthy volunteers.
Read the detailed description
RagweedMATAMPL (tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL®)) has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to ragweed pollen. MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile.
The ragweed pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities is not seen.
This was planned to be a phase I, double-blind, placebo-controlled study to evaluate the safety and tolerability of RagweedMATAMPL in healthy volunteers. Fifteen (15) volunteers were planned to be randomized to receive up to 4 subcutaneous injections of either increasing doses of RagweedMATAMPL or Placebo over 7 day intervals.
- Conditions
- Type I Hypersensitivity
- Being tested
- RagweedMATAMPL, Placebo
- Keywords
- allergy, allergoid, specific immunotherapy, ragweed, Tyrosine
- Medical subject headings
- Hypersensitivity, Immediate, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RagweedMATAMPLBiological
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| RagweedMATAMPL | Experimental | Not described Receives: Biological: RagweedMATAMPL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Recording of adverse events (AEs).
Measured: 29 days
Secondary outcomes (3)
Tolerability of different subcutaneous doses
Recording of adverse events (AEs).
Measured: 29 days
Tolerability of the cumulative subcutaneous dose
Recording of adverse events (AEs).
Measured: 29 days
Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startMay 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I HypersensitivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109759
- Sponsor's protocol ID
- RagweedMATAMPL102
- Other IDs
- P1DP05002
- Status last verified
- Jul 2021
- First submitted
- 3 May 2005
- Last updated
- 12 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Phase I Study to Evaluate the Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL® in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00109759
- Acronym / sponsor ID
- RagweedMATAMPL102
- Conditions
- Type I Hypersensitivity
- Keywords
- allergy, allergoid, specific immunotherapy, ragweed, Tyrosine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Jun 2005
- First posted
- 4 May 2005 (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 safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL) was planned to be evaluated. For this purpose, a total of 4 injections of either increasing doses of the study drug or placebo (tyrosine) was planned to be administered in 7-day intervals to healthy volunteers.
Detailed description
RagweedMATAMPL (tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL®)) has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to ragweed pollen. MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile.
The ragweed pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities is not seen.
This was planned to be a phase I, double-blind, placebo-controlled study to evaluate the safety and tolerability of RagweedMATAMPL in healthy volunteers. Fifteen (15) volunteers were planned to be randomized to receive up to 4 subcutaneous injections of either increasing doses of RagweedMATAMPL or Placebo over 7 day intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RagweedMATAMPL | Experimental | Biological: RagweedMATAMPL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Non-smoker and not using any nicotine products
- Negative skin prick test with a standard panel of marker allergen extracts (including ragweed allergen extract)
- Specific IgE for ragweed with class = 0
- No clinical history of IgE-mediated allergic diseases
- Subject agrees not to use any medication or herbal products during the study
Key exclusion criteria (23 listed)
- Clinical history or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
- Clinical history or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders.
- Any clinically significant (as determined by the Investigator) abnormal laboratory value at Visit 1
- Clinical history of auto-immune diseases or rheumatoid diseases.
- Contraindication to adrenaline
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 |
|---|---|---|
| RagweedMATAMPL | Biological | RagweedMATAMPL |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: 29 days
Recording of adverse events (AEs).
3 secondary outcomes
Tolerability of different subcutaneous doses
Time frame: 29 days
Tolerability of the cumulative subcutaneous dose
Time frame: 29 days
Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study
Time frame: 29 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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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 RagweedMATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics 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 9 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: withdrawn, as of the sponsor's last update on 12 Aug 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety and tolerability (time frame: 29 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 12 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.