Healthy VolunteersPhase 1NCT02828397
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects
A Phase 1 study testing REGN2222 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
Primary Objective: Determine blood concentrations of two formulations of REGN2222 Secondary Objective: Assess safety and tolerability of REGN2222 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN2222
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy man or woman aged 18 to 60 years
- Body weight between 50.0 kg and 95.0 kg, inclusive
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Hemoglobin not within normal limits
- Positive drug and alcohol screen test results at screening visits 1 and 2
- 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
- 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
2 sites in 1 country.
United States2 sites
Study site
Daytona Beach, Florida
Study site
Evansville, Indiana
About this study
Official title: A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects
Primary Objective: Determine blood concentrations of two formulations of REGN2222
Secondary Objective: Assess safety and tolerability of REGN2222
- Conditions
- Healthy Volunteers
- Being tested
- REGN2222
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN2222Drug
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug | Experimental | REGN2222 Reference Formulation Receives: Drug: REGN2222 |
| Test Drug | Experimental | REGN2222 Test Formulation Receives: Drug: REGN2222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum REGN2222 concentration-time curve (AUC)
Measured: Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)
Measured: Day 1 to Day 148 (end of study)
Secondary outcomes (2)
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Measured: Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)
Measured: Day 1 to Day 148 (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 posted11 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 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
- 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
- NCT02828397
- Sponsor's protocol ID
- R2222-HV-1520
- Status last verified
- Nov 2016
- First submitted
- 7 Jul 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 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 Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02828397
- Acronym / sponsor ID
- R2222-HV-1520
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Jul 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 REGN2222
Secondary Objective: Assess safety and tolerability of REGN2222
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: REGN2222REGN2222 Reference Formulation |
| Test Drug | Experimental | Drug: REGN2222REGN2222 Test Formulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy man or woman aged 18 to 60 years
- Body weight between 50.0 kg and 95.0 kg, inclusive
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (5 listed)
- Hemoglobin not within normal limits
- Positive drug and alcohol screen test results at screening visits 1 and 2
- 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
- Pregnant or breastfeeding women, and women of childbearing potential
- Sexually active men who are unwilling to practice adequate contraception 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 |
|---|---|---|
| REGN2222 | Drug | Reference Drug, Test Drug |
Primary outcome
Serum REGN2222 concentration-time curve (AUC)
Time frame: Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)
Time frame: Day 1 to Day 148 (end of study)
2 secondary outcomes
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Time frame: Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)
Time frame: Day 1 to Day 148 (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 4 Nov 2016.
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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
2 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 REGN2222 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 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 4 inclusion and 5 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Serum REGN2222 concentration-time curve (AUC) (time frame: Day 1 to Day 148 (end of study)). 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 4 Nov 2016.