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Safety and Tolerability Study of rBet v1 SLIT Tablets

NCT00889460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2009-04-29

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.

Conditions

  • Birch Pollen-Related Rhinoconjunctivitis
  • Rhinitis, Allergic, Seasonal

Interventions

BIOLOGICAL

rBet v 1

Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.

BIOLOGICAL

Placebo

Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Hans-Jorgen MALLING, Pr. MD · National University Hospital - Copenhagen - DENMARK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889460 on ClinicalTrials.gov