AzTrials
AzTrials

Multiple Sclerosis (MS)Phase 1C-851NCT01863069

Avonex®: Safety, Blood Levels and Effects

A Phase 1 study testing Interferon beta 1a and (IM) AVONEX® in people with Multiple Sclerosis (MS), run by Trio Medicines Ltd. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis (MS)
What is being tested?
Interferon beta 1a and (IM) AVONEX®
How many people
77 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2001to Oct 2001
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 43Show fewer
  • <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.
  • Abnormal baseline or screening blood tests exceeding any of the limits defined below:
  • Alanine transaminase (ALT) or aspartate transaminase (AST) or bilirubin > 2x the upper limit of normal (> 2x ULN)
  • Total white blood cell count (WBC) < 3700/mm3
  • Platelet count < 150,000/mm³
  • Hemoglobin < 12 g/dL
  • Plasma Creatinine > ULN
  • Prothrombin time (PT) or activated thromboplastin time (aPTT) > ULN
  • Positive for hepatitis C antibody, hepatitis B surface antigen (HBsAg), or HIV antibody.
  • An electrocardiogram (ECG) with a clinically significant abnormality (as determined by the investigator).
  • A chest radiograph (CXR) with a clinically significant abnormality (as determined by the investigator).
  • History of epilepsy or fits or unexplained blackouts.
  • Treatment History
  • Previous treatment with any interferon beta or any interferon alpha product.
  • Treatment with another investigational drug or approved therapy for investigational use within 3 months prior to the first day of dosing.
  • Except for contraceptives, vitamin/mineral supplements, acetaminophen (paracetamol), and/or ibuprofen, treatment with any medication including over-the-counter products within 48 hours prior to the first dose of study drug.
  • Miscellaneous
  • History of smoking within 6 months prior to the first day of dosing.
  • Abnormal screening urine cotinine level (defined as >100 ng/mL when performed by capillary column gas-liquid chromatography).
  • History of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to the first day of dosing.
  • Blood donation (one unit or more) within 1 month prior to the first day of dosing.
  • Vigorous exercise (as determined by the investigator) within 48 hours prior to the first dose of study drug.
  • Alcohol use within 24 hours prior to the first dose of study drug.
  • Female subjects who are currently pregnant or breast-feeding.
  • For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception. Women considering becoming pregnant while on study are to be excluded.
  • Positive screening or baseline urine drug screen
  • Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.
  • Current enrollment in any other study.
  • Previous participation in this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Medicines Research

    London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: A Single-centre Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Inhaled Formulation of AVONEX® (Interferon Beta-1a) in Healthy Volunteers

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:

Read more

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.

Being tested
Interferon beta 1a, (IM) AVONEX®
Keywords
inhaled, interferon beta-1a, healthy subjects
Medical subject headings
Multiple Sclerosis, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon beta 1aDrug

    Also called AVONEX

  • (IM) AVONEX®Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameter

    Serum concentrations of human interferon-beta

    Measured: 10 months

  2. Pharmacodynamic parameter

    Serum concentrations of neopterin and beta2-microglobulin

    Measured: 10 months

  3. Number of adverse events

    Adverse events throughout the study

    Measured: 10 months

  4. 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

    Measured: 10 months

  5. Pharmacodynamic paramter

    Cellular MxA protein as an exploratory analysis

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2013 (estimated)
  2. Study startJan 2001
  3. Primary completionOct 2001
  4. Study completionOct 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01863069
Sponsor's protocol ID
00-037
Acronym
C-851
Status last verified
May 2013
First submitted
20 May 2013
Last updated
27 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Interferon beta 1a and (IM) AVONEX® in people with Multiple Sclerosis (MS), run by Trio Medicines Ltd. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameter (time frame: 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01863069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in