Healthy VolunteersPhase 1NCT02516618
Study of Fasinumab (REGN475) in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing Fasinumab in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fasinumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Feb 2016
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female Japanese and Caucasian volunteers ≥20 and ≤55 years of age at the screening visit
- Japanese subjects must:
- Be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese
- Have maintained a Japanese lifestyle since leaving Japan
- Caucasian subjects must be Caucasian of European or Latin American descent
- Have a Body Mass Index (BMI) ≤ 35
- Be willing to refrain from taking NSAID medications (oral or topical) for 1 week prior to receiving study drug and for 16 weeks after study drug administration
Who cannot join
- History or presence at the screening visit of bone or joint disorders including but not limited to osteoarthritis, avascular necrosis, destructive arthropathy, pathologic fractures, osteonecrosis, rheumatoid arthritis, neuropathic joint arthropathy, lupus erythematosus, or inflammatory joint diseases
- History of joint-related events such as, but not limited to, total joint replacement (TJR) surgery, patella dislocation, hip dislocation, knee dislocation, injury to meniscus or knee ligaments (with or without surgical repair), or joint infections
- Trauma to any joint in the 30 days prior to the screening visit
- History of autonomic neuropathy, or diabetic neuropathy
- Evidence of autonomic neuropathy
- Presence of clinically relevant peripheral neuropathy
Show all 18Show fewer
- History or presence at the screening visit of orthostatic hypotension
- History or evidence at screening of heart block
- Resting heart rate of <50 or >100 beats per minute (bpm)
- History of poorly controlled hypertension:
- Congestive heart failure with NY Heart Classification of stage 3 or 4
- History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit
- Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/PK data
- HIV, hepatitis B, or hepatitis C positive by serological testing at the screening visit
- History or presence of malignancy within 5 years prior to screening, except subjects who have been treated successfully with no recurrence of basal or squamous cell carcinoma of the skin (< 1 year), in situ cervical cancer, or in situ ductal breast cancer
- Women of reproductive potential who have a positive serum pregnancy test result at the screening visit, or a positive urine pregnancy test result at the baseline visit, or who do not have their pregnancy test results at the baseline visit
- Pregnant or breast-feeding women
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug, whichever is longer, prior to the day 1 visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Fasinumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FasinumabDrug
Also called REGN475
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants in this cohort will receive dose 1 of Fasinumab or placebo Receives: Drug: Fasinumab; Drug: Placebo |
| Cohort 2 | Experimental | Participants in this cohort will receive dose 2 of Fasinumab or placebo Receives: Drug: Fasinumab; Drug: Placebo |
| Cohort 3 | Experimental | Participants in this cohort will receive dose 3 of Fasinumab or placebo Receives: Drug: Fasinumab; Drug: Placebo |
| Cohort 4 | Experimental | Participants in this cohort will receive dose 4 of Fasinumab or placebo Receives: Drug: Fasinumab; Drug: Placebo |
| Cohort 5 | Experimental | Participants in this cohort will receive dose 5 of Fasinumab or placebo Receives: Drug: Fasinumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.
Measured: Baseline to week 16 (End of Study)
Secondary outcomes (2)
Fasinumab serum concentrations over time
Measured: Baseline to week 16 (End of Study)
Presence of anti-fasinumab antibodies over time
Measured: Baseline to week 16 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516618
- Sponsor's protocol ID
- R475-PN-1516
- Status last verified
- May 2016
- First submitted
- 31 Jul 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT02516618
- Acronym / sponsor ID
- R475-PN-1516
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Aug 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 assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Fasinumab, Drug: PlaceboParticipants in this cohort will receive dose 1 of Fasinumab or placebo |
| Cohort 2 | Experimental | Drug: Fasinumab, Drug: PlaceboParticipants in this cohort will receive dose 2 of Fasinumab or placebo |
| Cohort 3 | Experimental | Drug: Fasinumab, Drug: PlaceboParticipants in this cohort will receive dose 3 of Fasinumab or placebo |
| Cohort 4 | Experimental | Drug: Fasinumab, Drug: PlaceboParticipants in this cohort will receive dose 4 of Fasinumab or placebo |
| Cohort 5 | Experimental | Drug: Fasinumab, Drug: PlaceboParticipants in this cohort will receive dose 5 of Fasinumab or placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female Japanese and Caucasian volunteers ≥20 and ≤55 years of age at the screening visit
- Japanese subjects must:
- Caucasian subjects must be Caucasian of European or Latin American descent
- Have a Body Mass Index (BMI) ≤ 35
- Be willing to refrain from taking NSAID medications (oral or topical) for 1 week prior to receiving study drug and for 16 weeks after study drug administration
Key exclusion criteria (18 listed)
- History or presence at the screening visit of bone or joint disorders including but not limited to osteoarthritis, avascular necrosis, destructive arthropathy, pathologic fractures, osteonecrosis, rheumatoid arthritis, neuropathic joint arthropathy, lupus erythematosus, or inflammatory joint diseases
- History of joint-related events such as, but not limited to, total joint replacement (TJR) surgery, patella dislocation, hip dislocation, knee dislocation, injury to meniscus or knee ligaments (with or without surgical repair), or joint infections
- Trauma to any joint in the 30 days prior to the screening visit
- History of autonomic neuropathy, or diabetic neuropathy
- Evidence of autonomic neuropathy
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 |
|---|---|---|
| FasinumabAlso: REGN475 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.
Time frame: Baseline to week 16 (End of Study)
2 secondary outcomes
Fasinumab serum concentrations over time
Time frame: Baseline to week 16 (End of Study)
Presence of anti-fasinumab antibodies over time
Time frame: Baseline to week 16 (End of Study)
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 12 May 2016.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 Fasinumab in people with Healthy Volunteers, run by Regeneron Pharmaceuticals 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 7 inclusion and 18 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 12 May 2016. 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. 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?
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo. (time frame: Baseline to week 16 (End of Study)). 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 12 May 2016.