Parkinson's DiseasePhase 1NCT02459886
Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
A Phase 1 study testing BIIB054 in people with Parkinson's Disease and Healthy, run by Biogen at 9 sites in United States.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of a range of single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy participants and participants with early Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Healthy
- What is being tested?
- BIIB054
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jul 2015to 20 Nov 2017
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women of childbearing potential and all men must practice effective contraception during the study and for 6 months after their last dose of study treatment.
- Must have a body mass index from 19 to 32 kg/m2, inclusive.
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
- For cohort 7 only:
- Diagnosis of idiopathic PD
Who cannot join
- History of cardiovascular disease.
- Subject smokes more than 5 cigarettes or the equivalent in tobacco daily.
- Surgery within 3 months prior to Day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the Investigator).
- History or positive test result for hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Research Site
Cleveland, Ohio, 44195
Research Site
Dallas, Texas, 75247
Research Site
Durham, North Carolina, 27705
Research Site
Evansville, Indiana, 47710
Research Site
Farmington Hills, Michigan, 48334
Research Site
Hallandale, Florida, 33009
Research Site
Oviedo, Florida, 32765-4515
Research Site
Spokane, Washington, 99202
Research Site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease
The primary objective of the study is to evaluate the safety and tolerability of a range of single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy participants and participants with early Parkinson's disease (PD). Secondary objectives of the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose administration and to evaluate the immunogenicity of BIIB054 after single-dose administration.
Read the detailed description
Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with early PD will be enrolled in Cohort 7
- Conditions
- Parkinson's Disease, Healthy
- Being tested
- BIIB054, Placebo
- Keywords
- alpha synuclein, PD
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB054Drug
IV infusion
PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single intravenous (IV) low dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
| Cohort 2 | Experimental | Single IV ascending dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
| Cohort 3 | Experimental | Single IV ascending dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
| Cohort 4 | Experimental | Single IV ascending dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
| Cohort 5 | Experimental | Single IV ascending dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
| Cohort 6 | Experimental | Single IV ascending dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
| Cohort 7 | Experimental | Single IV ascending dose infusion with staggered participant dosing Receives: Drug: BIIB054; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events/serious adverse events (AEs/SAEs),
After a range of single BIIB054 doses administered as a single IV infusion in healthy participants and participants with early Parkinson's Disease, clinical laboratory test data, vital signs, neurological and physical examination findings, 12-lead electrocardiogram (ECG) data, and brain magnetic resonance imaging (MRI) findings will be used in the evaluation of AEs/SAEs.
Measured: 20 Weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality.
Measured: 20 Weeks
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
Measured: 20 Weeks
Secondary outcomes (2)
Evaluate serum BIIB054 concentrations and PK parameters
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (0-∞), AUC from time 0 to time of the last measurable concentration (AUC0-tlast), maximum concentration (Cmax), time to Cmax (Tmax), elimination half-life (t1/2), and clearance (Cl), will be used to assess the serum PK profile of BIIB054 after single-dose administration.
Measured: 20 Weeks
evaluation of anti-BIIB054 antibodies in serum
evaluate the immunogenicity of BIIB054 after single-dose administration
Measured: 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start1 Jul 2015
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT02459886
- Sponsor's protocol ID
- 228HV101
- Status last verified
- Aug 2019
- First submitted
- 29 May 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02459886
- Acronym / sponsor ID
- 228HV101
- Conditions
- Parkinson's Disease, Healthy
- Keywords
- alpha synuclein, PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 2 Jun 2015 (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 the study is to evaluate the safety and tolerability of a range of single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy participants and participants with early Parkinson's disease (PD). Secondary objectives of the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose administration and to evaluate the immunogenicity of BIIB054 after single-dose administration.
Detailed description
Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with early PD will be enrolled in Cohort 7
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BIIB054, Drug: PlaceboSingle intravenous (IV) low dose infusion with staggered participant dosing |
| Cohort 2 | Experimental | Drug: BIIB054, Drug: PlaceboSingle IV ascending dose infusion with staggered participant dosing |
| Cohort 3 | Experimental | Drug: BIIB054, Drug: PlaceboSingle IV ascending dose infusion with staggered participant dosing |
| Cohort 4 | Experimental | Drug: BIIB054, Drug: PlaceboSingle IV ascending dose infusion with staggered participant dosing |
| Cohort 5 | Experimental | Drug: BIIB054, Drug: PlaceboSingle IV ascending dose infusion with staggered participant dosing |
| Cohort 6 | Experimental | Drug: BIIB054, Drug: PlaceboSingle IV ascending dose infusion with staggered participant dosing |
| Cohort 7 | Experimental | Drug: BIIB054, Drug: PlaceboSingle IV ascending dose infusion with staggered participant dosing |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All women of childbearing potential and all men must practice effective contraception during the study and for 6 months after their last dose of study treatment.
- Must have a body mass index from 19 to 32 kg/m2, inclusive.
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
- Diagnosis of idiopathic PD
Key exclusion criteria (6 listed)
- History of cardiovascular disease.
- Subject smokes more than 5 cigarettes or the equivalent in tobacco daily.
- Surgery within 3 months prior to Day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the Investigator).
- History or positive test result for hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
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 |
|---|---|---|
| BIIB054IV infusion | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| PlaceboIV infusion | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Adverse events/serious adverse events (AEs/SAEs),
Time frame: 20 Weeks
After a range of single BIIB054 doses administered as a single IV infusion in healthy participants and participants with early Parkinson's Disease, clinical laboratory test data, vital signs, neurological and physical examination findings, 12-lead electrocardiogram (ECG) data, and brain magnetic resonance imaging (MRI) findings will be used in the evaluation of AEs/SAEs.
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 20 Weeks
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality.
Montreal Cognitive Assessment (MoCA)
Time frame: 20 Weeks
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
2 secondary outcomes
Evaluate serum BIIB054 concentrations and PK parameters
Time frame: 20 Weeks
evaluation of anti-BIIB054 antibodies in serum
Time frame: 20 Weeks
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 8 Aug 2019.
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB054 in people with Parkinson's Disease and Healthy, run by Biogen at 9 sites 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 5 inclusion and 6 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. 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?
Adverse events/serious adverse events (AEs/SAEs), (time frame: 20 Weeks). The study lists 3 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 8 Aug 2019.