HealthyPhase 1NCT01943513
A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers
A Phase 1 study testing BIIB023 in people with Healthy, run by Biogen at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The secondary objectives of this study in this study population are: To determine whether muscle weakness induced by immobilization of the… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to May 2014
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Deemed healthy as determined by the Investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and physical examination at Baseline
- Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the time of Screening
- Willing to abstain from using tobacco and tobacco-containing products during the study
- Willing to limit the intake of alcohol to no more than 2 units per day throughout the study; exceptions are 48 hours prior to Screening, 48 hours prior to Day 1, and during the in-clinic immobilization period when no alcohol will be permitted. One unit of alcohol is defined as 12 fluid ounce (fl oz) of beer, 5 fl oz of wine, or 1.5 fl oz of liquor
- Willing to maintain a regular diet for the duration of the study and a recreational level of physical activity defined as participation in an exercise program or other physical activity at a level of intensity that does not exceed the level prior to study entry
- Practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after the last dose of study treatment.
Who cannot join
- History of or positive test result at Screening for human immunodeficiency virus (HIV).
- History or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject.
- Use of tobacco or tobacco-containing products within 3 months prior to Screening
- Known history of thrombophilia, hypercoagulopathy, or prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- History of physical activity consistent with endurance training or resistance training within 6 months prior to Screening
Show all 9Show fewer
- Any back, leg, knee, or shoulder complaints that may interfere with the use of crutches
- Prolonged travel (more than 6 hours) within 2 weeks prior to randomization.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Intravenous BIIB023 (Anti-TWEAK) on Lower Limb Muscle Mass and Strength During and After Knee-Joint Immobilization in Healthy Male Volunteers
The primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The secondary objectives of this study in this study population are:
- To determine whether muscle weakness induced by immobilization of the lower limb can be attenuated by BIIB023
- To assess the effect of BIIB023 on the recovery of muscle mass and strength after immobilization
- To assess the effect of BIIB023 on histological markers of muscle atrophy and regeneration
- To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism recovery kinetics
- To evaluate the safety and tolerability of BIIB023
- Conditions
- Healthy
- Being tested
- BIIB023, Placebo
- Keywords
- Muscle Disuse Atrophy
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB023Biological
Also called (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)
Intravenous (IV) infusions
PlaceboBiological
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| BIIB023 | Experimental | Participants receive intravenous (IV) infusions of BIIB023 Receives: Biological: BIIB023 |
| Placebo | Placebo comparator | Participants receive intravenous (IV) infusions of placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in the magnitude of muscle atrophy
Measured: between Day 14 and Day 42
Secondary outcomes (7)
Percentage change in the magnitude of muscle atrophy, measured by T1W-MRI analysis of the CSA of the triceps surae muscles of the immobilized limb
Measured: between Day 14 and Day 42
Percentage change in isometric knee-extension strength (torque), measured by dynamometry
Measured: between Day 14 and Day 42
Percentage change in isometric plantar-flexion strength (torque), measured by dynamometry
Measured: between Day 14 and Day 42
Percentage change in total CSA of Type I and II fibers, measured by histological analysis of muscle biopsy
Measured: between Day 14, Day 21, and Day 42
Change in density of satellite cells and other molecular markers of muscle regeneration, measured by histological analysis of muscle biopsy
Measured: between Day 14, Day 21, and Day 42
Change in the recovery of muscle oxidative metabolism, measured by near-infrared spectroscopy (NIRS) of the quadriceps femoris muscles
Measured: between Day 14 and Day 42
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionMay 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943513
- Sponsor's protocol ID
- 211HV103
- Status last verified
- Aug 2014
- First submitted
- 12 Sep 2013
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Intravenous BIIB023 (Anti-TWEAK) on Lower Limb Muscle Mass and Strength During and After Knee-Joint Immobilization in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01943513
- Acronym / sponsor ID
- 211HV103
- Conditions
- Healthy
- Keywords
- Muscle Disuse Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Sep 2013 (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.
The primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The secondary objectives of this study in this study population are:
- To determine whether muscle weakness induced by immobilization of the lower limb can be attenuated by BIIB023
- To assess the effect of BIIB023 on the recovery of muscle mass and strength after immobilization
- To assess the effect of BIIB023 on histological markers of muscle atrophy and regeneration
- To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism recovery kinetics
- To evaluate the safety and tolerability of BIIB023
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB023 | Experimental | Biological: BIIB023Participants receive intravenous (IV) infusions of BIIB023 |
| Placebo | Placebo comparator | Biological: PlaceboParticipants receive intravenous (IV) infusions of placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Deemed healthy as determined by the Investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and physical examination at Baseline
- Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the time of Screening
- Willing to abstain from using tobacco and tobacco-containing products during the study
- Willing to limit the intake of alcohol to no more than 2 units per day throughout the study; exceptions are 48 hours prior to Screening, 48 hours prior to Day 1, and during the in-clinic immobilization period when no alcohol will be permitted. One unit of alcohol is defined as 12 fluid ounce (fl oz) of beer, 5 fl oz of wine, or 1.5 fl oz of liquor
- Willing to maintain a regular diet for the duration of the study and a recreational level of physical activity defined as participation in an exercise program or other physical activity at a level of intensity that does not exceed the level prior to study entry
Key exclusion criteria (9 listed)
- History of or positive test result at Screening for human immunodeficiency virus (HIV).
- History or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject.
- Use of tobacco or tobacco-containing products within 3 months prior to Screening
- Known history of thrombophilia, hypercoagulopathy, or prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
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 |
|---|---|---|
| BIIB023Also: (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)Intravenous (IV) infusions | Biological | BIIB023 |
| PlaceboMatched placebo | Biological | Placebo |
Primary outcome
Percentage change in the magnitude of muscle atrophy
Time frame: between Day 14 and Day 42
7 secondary outcomes
Percentage change in the magnitude of muscle atrophy, measured by T1W-MRI analysis of the CSA of the triceps surae muscles of the immobilized limb
Time frame: between Day 14 and Day 42
Percentage change in isometric knee-extension strength (torque), measured by dynamometry
Time frame: between Day 14 and Day 42
Percentage change in isometric plantar-flexion strength (torque), measured by dynamometry
Time frame: between Day 14 and Day 42
Percentage change in total CSA of Type I and II fibers, measured by histological analysis of muscle biopsy
Time frame: between Day 14, Day 21, and Day 42
Change in density of satellite cells and other molecular markers of muscle regeneration, measured by histological analysis of muscle biopsy
Time frame: between Day 14, Day 21, and Day 42
Change in the recovery of muscle oxidative metabolism, measured by near-infrared spectroscopy (NIRS) of the quadriceps femoris muscles
Time frame: between Day 14 and Day 42
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 156
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 3 Sep 2014.
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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.
Medical Director study director
Biogen
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 BIIB023 in people with Healthy, run by Biogen at 1 site in United States.
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 6 inclusion and 9 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 3 Sep 2014. 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 States. 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. Some participants in this study may receive a placebo. 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?
Percentage change in the magnitude of muscle atrophy (time frame: between Day 14 and Day 42). 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 3 Sep 2014.