Avonex®: Safety, Blood Levels and Effects

NCT01863069 | Completed Phase 1

• 1 other identifier: 00-037
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective was to determine the tolerability of a new inhaled formulation of interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and compared with standard intramuscular (IM) AVONEX® when given as a single dose. The additional objectives were: To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose. To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose.

Conditions

Multiple Sclerosis (MS)

Keywords

inhaled; interferon beta-1a; healthy subjects

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic parameter

  Serum concentrations of human interferon-beta

  10 months

• Pharmacodynamic parameter

  Serum concentrations of neopterin and beta2-microglobulin

  10 months

• Number of adverse events

  Adverse events throughout the study

  10 months

• Clinically relevant changes from baseline in safety assessments

  Routine physical examination, ECG, safety tests of blood/urine, CXR, oximetry, full pulmonary function tests, spirometry, Dyspnea scale

  10 months

• Pharmacodynamic paramter

  Cellular MxA protein as an exploratory analysis

  10 months

Interventions

Interferon beta 1a DRUG

Also known as: AVONEX

(IM) AVONEX® DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be between the ages of 18 and 45 years, inclusive.
• Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline).
• Must give written informed consent.

You may not qualify if:

• History of severe allergic or anaphylactic reactions.
• History of hypersensitivity to acetaminophen (paracetamol) or ibuprofen. Subjects in Part III of the study will also be excluded for history of hypersensitivity to human albumin.
• History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
• History of asthma, as defined by wheezing, dyspnea, or cough requiring treatment with either inhaled beta-2-agonists, inhaled corticosteroids, inhaled cromolyn sodium, or oral steroids or history of chronic obstructive pulmonary disease (including chronic bronchitis, bronchiectasis, or emphysema).
• Abnormal screening full pulmonary function tests (PFTs) or baseline spirometry (predicted values are those of the European Coal and Steel Community (Quanjer, 1983)) or abnormal screening or baseline oximetry, as defined by any one of the following:
• \<80% predicted Forced expiratory volume (FEV1)
• \<80% predicted forced vital capacity (FVC)
• \<70% FEV1/FVC ratio
• \<80% predicted total lung capacity (TLC)
• \<80% predicted diffusion capacity, corrected for hemoglobin (DLCOcorr).
• Oxygen saturation of \<96% on room air at rest.
• Inability to perform pulmonary function tests in a reproducible manner.
• Inability to use the Pulmonary Delivery System device correctly.
• Abnormal baseline or screening dyspnea scale, defined as a score of equal to or greater than 1 on the modified Medical Research Council (MRC) scale.
• Fever (body temperature \>38 degrees C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to the first day of dosing.

Sponsors & Collaborators

• Trio Medicines Ltd.: lead
• Biogen: collaborator

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Respiratory Aspiration

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Steve Warrington

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 27, 2013
• Study Start: January 1, 2001
• Primary Completion: October 1, 2001
• Study Completion: October 1, 2001
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

GB (1)