Status:
WITHDRAWN
Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)
Lead Sponsor:
Allergy Therapeutics
Conditions:
Type I Hypersensitivity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 ...
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 hyperse...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00109759
Start Date
May 1 2005
End Date
June 1 2005
Last Update
August 12 2021
Active Locations (1)
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1
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2