HealthyPhase 1NCT01416207
A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects
A Phase 1 study testing Avonex in people with Healthy, run by Biogen at 1 site in China.
Trial summary
Rationale for the Study: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Avonex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Oct 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Subjects of Chinese origin (at least both maternal and paternal grandparents of Chinese origin).
- Body mass index (BMI) within the range of 18.5 to 30 kg/m2 (inclusive).
- All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Who cannot join
- History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day 1.
- History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day 1.
- Any clinically significant presence (as determined by the Investigator) of cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease.
- Positive test result for hepatitis C antibody (HCV Ab), or current hepatitis B infection at Screening.
- Known history of human immunodeficiency virus (HIV).
- Clinically significant abnormal laboratory values.
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- History of alcohol abuse (as defined by the Investigator), or a positive blood screen test for presence for alcohol at Screening.
- History of drug abuse (as defined by the Investigator), or a positive urinary screen test for presence of cocaine and morphine.
- Premalignant and malignant disease.
- History of clinically significant severe allergic or anaphylactic reactions.
- Known allergy to any component of the Avonex formulation.
- History of hypersensitivity or intolerance to prophylactic analgesic medication that would preclude use during the study.
- Clinically significant abnormal electrocardiogram (ECG) values as determined by the Investigator.
- Known allergy to interferon beta-1a.
- Active bacterial or viral infection.
- Female subjects who are pregnant or currently breastfeeding.
- Previous participation in another investigational drug study within the last 1 month or 7 half-lives, whichever is longer, or previous participation in this study.
- Treatment with any prescription medication within 14 days of Day 1.
- Treatment with any over-the-counter products within the 14 days prior to Day 1.
- Donation of blood (500 mL or greater) within 56 days prior to Day 1.
- Inability to comply with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Rationale for the Study:
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.
Study Design:
This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.
Read the detailed description
Rationale for the Study:
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.
Study Design:
This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.
Four Avonex IM injections will be administered in this study. Due to the long-term use of Avonex by MS patients, a multiple-dose PK/PD study is necessary in order to provide adequate information to evaluate changes in drug concentrations over time in Chinese healthy subjects. Serum levels of interferon beta in Caucasian healthy volunteers have been shown to peak between 3 and 15 hours after administration of Avonex IM at the dose being used in this study and have been shown to decline at a rate consistent with a 10-hour elimination half-life; therefore, accumulation of interferon beta following multiple weekly Avonex IM injections is not anticipated.
Exposure of healthy subjects to multiple doses of Avonex in this study is not anticipated to present safety or tolerability issues based on experience from previous Avonex studies that have been conducted in healthy volunteer subjects and MS patients. Flu-like symptoms associated with this dose of Avonex have generally been mostly of mild-to-moderate intensity and of short duration, typically experienced within the first 24 hours after injection. Prophylactic analgesic medication must be administered prior to each Avonex injection during the study which is a recommended practice with the use of interferon therapies in order to ameliorate flu-like symptoms.
Study Location:
China, at 1 Phase 1 study site.
Duration of Treatment and Follow-up:
Approximately 2 months, including a 28-day Screening and Baseline period, a 3-week Treatment and blood sampling period and a 14-day Follow-Up period.
Statistical Methods:
PK/PD parameters will be calculated using non-compartmental methods. Summary statistics for each PK/PD parameter will be calculated. Mean concentration values will be plotted over time both on a linear and a logarithmic scale.
The incidence of treatment-emergent AEs will be summarized. Vital signs will be examined to determine the incidence of clinically relevant abnormalities.
Laboratory evaluations will be assessed to determine the incidence of abnormalities. Changes in laboratory evaluations will be summarized using shift tables and summary statistics.
- Conditions
- Healthy
- Being tested
- Avonex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvonexDrug
Also called Interferon-β1a
4 weekly injections of Avonex (IM)
| Study group | Role | What they receive |
|---|---|---|
| Avonex | Experimental | 4 weekly injections of Avonex (IM) Receives: Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Participants will be followed for the duration of the study; and expected 2 months
Tmax
Measured: Participants will be followed for the duration of the study; and expected 2 months
AUC 0-t
Measured: Participants will be followed for the duration of the study; and expected 2 months
AUC 0-infinity
Measured: Participants will be followed for the duration of the study; and expected 2 months
T 1/2
Measured: Participants will be followed for the duration of the study; and expected 2 months
Tlag
Measured: Participants will be followed for the duration of the study; and expected 2 months
Ka
Measured: Participants will be followed for the duration of the study; and expected 2 months
T 1/2ab
Measured: Participants will be followed for the duration of the study; and expected 2 months
Kcl
Measured: Participants will be followed for the duration of the study; and expected 2 months
Kir
Measured: Participants will be followed for the duration of the study; and expected 2 months
Emax
Measured: Participants will be followed for the duration of the study; and expected 2 months
Tmax(E)
Measured: Participants will be followed for the duration of the study; and expected 2 months
Eauc
Measured: Participants will be followed for the duration of the study; and expected 2 months
Induction ratio
Measured: Participants will be followed for the duration of the study; and expected 2 months
T1/2 return to baseline
Measured: Participants will be followed for the duration of the study; and expected 2 months
Secondary outcomes (6)
Number of Adverse Events as a measure of safety and tolerability
Measured: Participants will be followed for the duration of the study; and expected 2 months
Number of Serious Adverse Events as a measure of safety and tolerability
Measured: Participants will be followed for the duration of the study; and expected 2 months
Changes in lab assessments
Measured: Participants will be followed for the duration of the study; and expected 2 months
Changes in vital signs
Measured: Participants will be followed for the duration of the study; and expected 2 months
Changes in physical examinations
Measured: Participants will be followed for the duration of the study; and expected 2 months
Changes in ECGs
Measured: Participants will be followed for the duration of the study; and expected 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416207
- Sponsor's protocol ID
- 108HV105
- Status last verified
- Nov 2011
- First submitted
- 30 Jun 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT01416207
- Acronym / sponsor ID
- 108HV105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale for the Study:
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.
Study Design:
This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.
Detailed description
Rationale for the Study:
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.
Study Design:
This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.
Four Avonex IM injections will be administered in this study. Due to the long-term use of Avonex by MS patients, a multiple-dose PK/PD study is necessary in order to provide adequate information to evaluate changes in drug concentrations over time in Chinese healthy subjects. Serum levels of interferon beta in Caucasian healthy volunteers have been shown to peak between 3 and 15 hours after administration of Avonex IM at the dose being used in this study and have been shown to decline at a rate consistent with a 10-hour elimination half-life; therefore, accumulation of interferon beta following multiple weekly Avonex IM injections is not anticipated.
Exposure of healthy subjects to multiple doses of Avonex in this study is not anticipated to present safety or tolerability issues based on experience from previous Avonex studies that have been conducted in healthy volunteer subjects and MS patients. Flu-like symptoms associated with this dose of Avonex have generally been mostly of mild-to-moderate intensity and of short duration, typically experienced within the first 24 hours after injection. Prophylactic analgesic medication must be administered prior to each Avonex injection during the study which is a recommended practice with the use of interferon therapies in order to ameliorate flu-like symptoms.
Study Location:
China, at 1 Phase 1 study site.
Duration of Treatment and Follow-up:
Approximately 2 months, including a 28-day Screening and Baseline period, a 3-week Treatment and blood sampling period and a 14-day Follow-Up period.
Statistical Methods:
PK/PD parameters will be calculated using non-compartmental methods. Summary statistics for each PK/PD parameter will be calculated. Mean concentration values will be plotted over time both on a linear and a logarithmic scale.
The incidence of treatment-emergent AEs will be summarized. Vital signs will be examined to determine the incidence of clinically relevant abnormalities.
Laboratory evaluations will be assessed to determine the incidence of abnormalities. Changes in laboratory evaluations will be summarized using shift tables and summary statistics.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avonex | Experimental | Drug: Avonex4 weekly injections of Avonex (IM) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Subjects of Chinese origin (at least both maternal and paternal grandparents of Chinese origin).
- Body mass index (BMI) within the range of 18.5 to 30 kg/m2 (inclusive).
- All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Key exclusion criteria (21 listed)
- History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day 1.
- History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day 1.
- Any clinically significant presence (as determined by the Investigator) of cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease.
- Positive test result for hepatitis C antibody (HCV Ab), or current hepatitis B infection at Screening.
- Known history of human immunodeficiency virus (HIV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvonexAlso: Interferon-β1a4 weekly injections of Avonex (IM) | Drug | Avonex |
Primary outcome
Cmax
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Tmax
Time frame: Participants will be followed for the duration of the study; and expected 2 months
AUC 0-t
Time frame: Participants will be followed for the duration of the study; and expected 2 months
AUC 0-infinity
Time frame: Participants will be followed for the duration of the study; and expected 2 months
T 1/2
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Tlag
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Ka
Time frame: Participants will be followed for the duration of the study; and expected 2 months
T 1/2ab
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Kcl
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Kir
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Emax
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Tmax(E)
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Eauc
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Induction ratio
Time frame: Participants will be followed for the duration of the study; and expected 2 months
T1/2 return to baseline
Time frame: Participants will be followed for the duration of the study; and expected 2 months
6 secondary outcomes
Number of Adverse Events as a measure of safety and tolerability
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Number of Serious Adverse Events as a measure of safety and tolerability
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Changes in lab assessments
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Changes in vital signs
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Changes in physical examinations
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Changes in ECGs
Time frame: Participants will be followed for the duration of the study; and expected 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avonex in people with Healthy, run by Biogen at 1 site in China.
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 4 inclusion and 21 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 4 Nov 2011. 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 China. 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?
Cmax (time frame: Participants will be followed for the duration of the study; and expected 2 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2011.