HealthyPhase 1NCT02741739
Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects
A Phase 1 study testing REGN1033 in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
Primary Objective: Determine blood concentrations of two formulations of REGN1033. Secondary Objective: Assess safety and tolerability of REGN1033. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REGN1033
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years
- Body weight between 50.0 kg and 95.0 kg
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing
- Hemoglobin not within normal limits
- Positive drug and alcohol screen test results at screening visits 1 and 2
- Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
- Recent use (within 3 months prior to screening) of androgenic steroids
- Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
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- Previous exposure to any biological therapeutic agent, except vaccines
- Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
- Pregnant or breastfeeding women, and women of childbearing potential
- Sexually active men who are unwilling to practice adequate contraception during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects
Primary Objective: Determine blood concentrations of two formulations of REGN1033.
Secondary Objective: Assess safety and tolerability of REGN1033.
- Conditions
- Healthy
- Being tested
- REGN1033
- Keywords
- Drug concentration, REGN1033, blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN1033Drug
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug | Experimental | REGN1033 Reference Formulation Receives: Drug: REGN1033 |
| Test Drug | Experimental | REGN1033 Test Formulation Receives: Drug: REGN1033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum REGN1033 concentration-time curve (AUC)
Measured: Pre-dose to day 57
Peak REGN1033 concentration (Cmax)
Measured: Pre-dose to day 57
Secondary outcomes (2)
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Measured: Day 1 to end of study (Day 57)
Presence or absence of anti-drug antibody (ADA)
Measured: Day 1 to end of study (Day 57)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionMay 2016
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 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
- None (open label)
- Enrolment
- 28 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
- NCT02741739
- Sponsor's protocol ID
- R1033-HV-1503
- Status last verified
- Oct 2016
- First submitted
- 13 Apr 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02741739
- Acronym / sponsor ID
- R1033-HV-1503
- Conditions
- Healthy
- Keywords
- Drug concentration, REGN1033, blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Apr 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.
Primary Objective: Determine blood concentrations of two formulations of REGN1033.
Secondary Objective: Assess safety and tolerability of REGN1033.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Drug | Experimental | Drug: REGN1033REGN1033 Reference Formulation |
| Test Drug | Experimental | Drug: REGN1033REGN1033 Test Formulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years
- Body weight between 50.0 kg and 95.0 kg
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (10 listed)
- Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing
- Hemoglobin not within normal limits
- Positive drug and alcohol screen test results at screening visits 1 and 2
- Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
- Recent use (within 3 months prior to screening) of androgenic steroids
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 |
|---|---|---|
| REGN1033 | Drug | Reference Drug, Test Drug |
Primary outcome
Serum REGN1033 concentration-time curve (AUC)
Time frame: Pre-dose to day 57
Peak REGN1033 concentration (Cmax)
Time frame: Pre-dose to day 57
2 secondary outcomes
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Time frame: Day 1 to end of study (Day 57)
Presence or absence of anti-drug antibody (ADA)
Time frame: Day 1 to end of study (Day 57)
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 14 Oct 2016.
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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.
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 REGN1033 in people with Healthy, 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 4 inclusion and 10 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 14 Oct 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?
Serum REGN1033 concentration-time curve (AUC) (time frame: Pre-dose to day 57). The study lists 2 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 14 Oct 2016.