search
Back to results

Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)

Primary Purpose

Type I Hypersensitivity

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
RagweedMATAMPL
Placebo
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Hypersensitivity focused on measuring allergy, allergoid, specific immunotherapy, ragweed, Tyrosine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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.

Sites / Locations

  • Allied Research International Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RagweedMATAMPL

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability
Recording of adverse events (AEs).

Secondary Outcome Measures

Tolerability of different subcutaneous doses
Recording of adverse events (AEs).
Tolerability of the cumulative subcutaneous dose
Recording of adverse events (AEs).
Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study

Full Information

First Posted
May 3, 2005
Last Updated
August 5, 2021
Sponsor
Allergy Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT00109759
Brief Title
Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergy Therapeutics

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Hypersensitivity
Keywords
allergy, allergoid, specific immunotherapy, ragweed, Tyrosine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RagweedMATAMPL
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
RagweedMATAMPL
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Recording of adverse events (AEs).
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Tolerability of different subcutaneous doses
Description
Recording of adverse events (AEs).
Time Frame
29 days
Title
Tolerability of the cumulative subcutaneous dose
Description
Recording of adverse events (AEs).
Time Frame
29 days
Title
Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study
Time Frame
29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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.
Facility Information:
Facility Name
Allied Research International Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)

We'll reach out to this number within 24 hrs