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Safety of ALK Ragweed Tablet

Primary Purpose

Allergy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALK Ragweed Tablet

About this trial

This is an interventional treatment trial for Allergy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ragweed pollen induced rhinoconjunctivitis Adults of either sex (18-50 years of age) Positive skin prick test to ragweed Exclusion Criteria: Previous treatment with immunotherapy

Sites / Locations

Healthcare Discoveries Inc.

Outcomes

Primary Outcome Measures

Assessment of safety by recording of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT00330083

First Posted

May 23, 2006

Last Updated

September 20, 2007

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT00330083

Brief Title

Safety of ALK Ragweed Tablet

Official Title

A RANDOMIZED, MULTIPLE DOSE, DOSE-ESCALATION, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I TRIAL INVESTIGATING THE OPTIMAL SAFE DOSE OF ALK RAGWEED TABLET AMBROSIA ARTEMISIIFOLIA IN ADULT SUBJECTS WITH SEASONAL RHINOCONJUNCTIVITIS CAUSED BY RAGWEED POLLEN ALLERGY

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

5. Study Description

Brief Summary

This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

ALK Ragweed Tablet

Primary Outcome Measure Information:

Title

Assessment of safety by recording of adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ragweed pollen induced rhinoconjunctivitis Adults of either sex (18-50 years of age) Positive skin prick test to ragweed Exclusion Criteria: Previous treatment with immunotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George J. Atiee, MD

Organizational Affiliation

Healthcare Discoveries Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Healthcare Discoveries Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26507708

Citation

Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.

Results Reference

derived

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Safety of ALK Ragweed Tablet

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