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

August 5, 2021 updated by: Allergy Therapeutics

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4W 1N2
        • Allied Research International Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: RagweedMATAMPL
Biological: RagweedMATAMPL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 29 days
Recording of adverse events (AEs).
29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of different subcutaneous doses
Time Frame: 29 days
Recording of adverse events (AEs).
29 days
Tolerability of the cumulative subcutaneous dose
Time Frame: 29 days
Recording of adverse events (AEs).
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
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergy Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (Estimate)

May 4, 2005

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RagweedMATAMPL102
  • P1DP05002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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