Healthy VolunteersPhase 1NCT02870400
A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
A Phase 1 study testing REGN2477 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN2477
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2016to 12 Jan 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
- A body mass index (BMI) between 18 to 30 kg/m2, inclusive
- Provide a signed informed consent
Who cannot join
- Significant illness or history of significant illness
- Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
- Current smoker or former smoker who has stopped smoking within 3 months prior to screening
- Positive urine drug test results during screening, or history of drug or alcohol abuse
- Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
- History of diabetes
Show all 18Show fewer
- Abnormal blood pressure (BP)
- History of gynecological disorders or malignancies; history of breast malignancies; or history of benign gynecological or breast lesions that require medical treatment or follow up
- Reduced renal function
- Known history of chronic hepatitis or HIV
- Clinically significant ECG abnormalities
- Participation in any clinical research study within 30 days, or 5 halflives, of the study drug, whichever is greater, or for longer periods per regional requirements, prior to the screening visit
- Exposure to any biological drugs within 3 months of the screening visit (the name of the drug and duration of previous exposure will be recorded). Vaccination within 4 weeks of screening visit.
- History of hypersensitivity reactions to vaccines or other biologics
- History of hypersensitivity to doxycycline or other tetracycline antibiotics
- History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab
- Subject using hormone replacement therapy or thyroid replacement therapy will be excluded, unless they have been on stable doses of such therapy for at least 6 months and will remain on the same stable dose through the duration of the trial
- Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential
The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.
- Conditions
- Healthy Volunteers
- Being tested
- REGN2477, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN2477Drug
Participants will receive ascending doses of REGN2477
PlaceboDrug
Participants will receive matching placebo
| Study group | Role | What they receive |
|---|---|---|
| REGN2477 | Experimental | Cohorts 1 - 5 will receive REGN2477 Receives: Drug: REGN2477 |
| Placebo | Experimental | Cohorts 1 - 5 will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
Measured: Day 1 to Day 113
Secondary outcomes (2)
Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time
Measured: Day 1 to Day 113
Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time
Measured: Day 1 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 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
- NCT02870400
- Sponsor's protocol ID
- R2477-HV-1525
- Status last verified
- Feb 2017
- First submitted
- 12 Aug 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential
- ClinicalTrials.gov ID
- NCT02870400
- Acronym / sponsor ID
- R2477-HV-1525
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 17 Aug 2016 (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 single ascending doses of REGN2477 in healthy women not of childbearing potential.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN2477 | Experimental | Drug: REGN2477Cohorts 1 - 5 will receive REGN2477 |
| Placebo | Experimental | Drug: PlaceboCohorts 1 - 5 will receive placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
- A body mass index (BMI) between 18 to 30 kg/m2, inclusive
- Provide a signed informed consent
Key exclusion criteria (18 listed)
- Significant illness or history of significant illness
- Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
- Current smoker or former smoker who has stopped smoking within 3 months prior to screening
- Positive urine drug test results during screening, or history of drug or alcohol abuse
- Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
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 |
|---|---|---|
| REGN2477Participants will receive ascending doses of REGN2477 | Drug | REGN2477 |
| PlaceboParticipants will receive matching placebo | Drug | Placebo |
Primary outcome
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
Time frame: Day 1 to Day 113
2 secondary outcomes
Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time
Time frame: Day 1 to Day 113
Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time
Time frame: Day 1 to Day 113
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 20 Feb 2017.
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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 REGN2477 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
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 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 20 Feb 2017. 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 Belgium. 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?
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477 (time frame: Day 1 to Day 113). 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 20 Feb 2017.