Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109759
Status:
WITHDRAWN
Last Update Posted:
2021-08-12
First Post:
2005-05-03
Brief Title:
Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL Monophosphoryl Lipid A
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P1DP05002 | None | None | None |