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Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

NCT00396149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2013-06-27

No results posted yet for this study

Summary

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Conditions

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

Interventions

BIOLOGICAL

Placebo

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

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 50 to 300 µg rBet v 1.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Hans-Jorgen MALLING, Professor · National University Hospital, Copenhagen

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
2006-11-30
Primary Completion
2007-03-31
Completion
2007-06-30

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 NCT00396149 on ClinicalTrials.gov