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

NCT00109759 | Withdrawn Phase 1

• 2 other identifiers: RagweedMATAMPL102P1DP05002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type I Hypersensitivity

Keywords

allergy; allergoid; specific immunotherapy; ragweed; Tyrosine

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Recording of adverse events (AEs).

  29 days

Secondary Outcomes (3)

• Tolerability of different subcutaneous doses

  29 days

• Tolerability of the cumulative subcutaneous dose

  29 days

• Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study

  29 days

Study Arms (2)

RagweedMATAMPL

EXPERIMENTAL

Biological: RagweedMATAMPL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RagweedMATAMPL BIOLOGICAL

RagweedMATAMPL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: May 1, 2005
• Study Completion: June 1, 2005
• Last Updated: August 12, 2021

Record last verified: 2021-07

Locations

CA (1)