HealthyPhase 1NCT01484600
Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers
A Phase 1 study testing REGN668: Injection Rate 1 and REGN668: Injection Rate 2 in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REGN668: Injection Rate 1 and REGN668: Injection Rate 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Feb 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects 18 to 55 years of age.
- Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive.
- NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal resting blood pressure and heart rate
- Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
Who cannot join
- History or presence of currently relevant medical conditions, including any cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, psychiatric, systemic, ocular, infectious or parasitic disease, or signs of acute illness.
- Administration of any medications within 1 week before randomization, other than vitamins, nutritional supplements, or low doses of aspirin taken prophylactically.
- Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to randomization. Subjects must be willing to maintain a relatively constant level of exercise during the study and refrain from unusually strenuous physical activities
- Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit.
- History of substance (eg. drug or alcohol) abuse or regular (daily) smoking within a year prior to randomization or positive results on urine drug screen.
- Excessive consumption of beverages with xanthine derivates (caffeine, theophylline, theobromine), such as coffee, tea, cola, or yerba mate (more than 4 cups or glasses per day).
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- Hospitalization for any reason within 60 days of randomization.
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of the investigational drug, whichever is longer, prior to the randomization visit.
- Live/attenuated vaccinations within 12 weeks of randomization or during the study.
- Tuberculosis vaccination within the last year.
- Previous exposure to any other biological agent within 12 months of randomization.
- History of a hypersensitivity reaction to doxycycline or other tetracyclines.
- Recent travel (within 12 months of randomization) to areas endemic for parasitic helminthes, such as developing countries, particularly in Africa and the tropical and subtropical regions of Asia.
- Pregnant or breast-feeding women.
- Unwilling to use adequate birth control if of reproductive potential and sexually active
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers.
- Conditions
- Healthy
- Being tested
- REGN668: Injection Rate 1, REGN668: Injection Rate 2
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN668: Injection Rate 1Drug
Subjects will receive REGN668 via SC injection
REGN668: Injection Rate 2Drug
Subjects will receive study drug via alternate delivery (if necessary)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: REGN668: Injection Rate 1 |
| Group 2 | Experimental | Not described Receives: Drug: REGN668: Injection Rate 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Baseline through day 64 (end of study)
Secondary outcomes (2)
Pharmacokinetic (PK) profile of REGN668
Measured: Baseline through day 64
Incidence of anti-REGN668 antibodies
Measured: Day 29 and Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484600
- Sponsor's protocol ID
- R668-HV-1108
- Status last verified
- Mar 2012
- First submitted
- 30 Nov 2011
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.
PubMed 32348036
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01484600
- Acronym / sponsor ID
- R668-HV-1108
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Dec 2011 (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.
This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: REGN668: Injection Rate 1 |
| Group 2 | Experimental | Drug: REGN668: Injection Rate 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects 18 to 55 years of age.
- Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive.
- NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal resting blood pressure and heart rate
- Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
Key exclusion criteria (15 listed)
- History or presence of currently relevant medical conditions, including any cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, psychiatric, systemic, ocular, infectious or parasitic disease, or signs of acute illness.
- Administration of any medications within 1 week before randomization, other than vitamins, nutritional supplements, or low doses of aspirin taken prophylactically.
- Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to randomization. Subjects must be willing to maintain a relatively constant level of exercise during the study and refrain from unusually strenuous physical activities
- Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit.
- History of substance (eg. drug or alcohol) abuse or regular (daily) smoking within a year prior to randomization or positive results on urine drug screen.
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 |
|---|---|---|
| REGN668: Injection Rate 1Subjects will receive REGN668 via SC injection | Drug | Group 1 |
| REGN668: Injection Rate 2Subjects will receive study drug via alternate delivery (if necessary) | Drug | Group 2 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Baseline through day 64 (end of study)
2 secondary outcomes
Pharmacokinetic (PK) profile of REGN668
Time frame: Baseline through day 64
Incidence of anti-REGN668 antibodies
Time frame: Day 29 and Day 64
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 Mar 2012.
- Derived from this study: PubMed 32348036Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.
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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 REGN668: Injection Rate 1 and REGN668: Injection Rate 2 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 5 inclusion and 15 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 Mar 2012. 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?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Baseline through day 64 (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01484600, which also lists 1 linked publication.
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 Mar 2012.