Overview

Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers

Status:
Unknown status

Trial end date:
2013-12-01

Target enrollment:

Participant gender:

Summary

The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches, and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy volunteers as well as in patients. This study is designed to determine whether a titration of dosing reduces the frequency and severity of the FLS. A reported study with another interferon (interferon beta), demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing was used. This study will compare the effects of the standard dose regimen with a titration regimen in healthy volunteers.

Phase:

Phase 1

Details

Lead Sponsor:

Vidara Therapeutics Research Ltd

Treatments:

Interferon-gamma
Interferons