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Phase I BP Interferon (IFN) Beta-001

NCT02515695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-08-06

No results posted yet for this study

Summary

Phase I study aiming at:

* assessing the absolute bioavailability, pharmacokinetic profile, and dose proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after i.v. and s.c. administration as well as the pharmacodynamic profile to create the link with available surrogate markers investigated with both formulations used clinically, lyophilisate with HSA (HSA+) and solution without HSA (HSA-);
* gathering further information on safety and tolerability of interferon beta-1a over dose range,including local and systemic tolerance, body temperature, vital signs, and a battery of exploratory sickness behavior tests.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Interferon beta-1a

6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution

Sponsors & Collaborators

  • BioPartners GmbH

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Jérôme Biollaz, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-07-31
Completion
2005-07-31

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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 NCT02515695 on ClinicalTrials.gov