Healthy VolunteersPhase 1NCT01933763
An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193
A Phase 1 study testing REGN1193 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN1193
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women 18 to 45 years of age (inclusive)
- Body mass index 18.0 to 30.0 kg/m^2 (inclusive)
- Normal standard 12-lead ECG
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- For sexually active men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during and for up to 3 months after participation in the study.
Who cannot join
- Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
- History of drug or alcohol abuse within a year prior to the screening visit
- Current regular smoking, or a history of smoking greater than ½ pack
- Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subject's participation in this study
- 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
Show all 11Show fewer
- Hospitalization for any reason within 60 days of screening
- History or presence of malignancy (including carcinoma in situ) prior to the screening visit
- Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
- Pregnant or breast-feeding women
- (The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).
Trial locations and contacts
1 site in 1 country.
About this study
Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- REGN1193, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN1193Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in Group A will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. Receives: Drug: REGN1193; Other: Placebo |
| Group B | Experimental | Participants in Group B will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. Receives: Drug: REGN1193; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of TEAEs
The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.
Measured: day 1 to day 106
Secondary outcomes (1)
Serum concentration
Serum concentrations of REGN1193 over time
Measured: day 1 to day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJan 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 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
- NCT01933763
- Sponsor's protocol ID
- R1193-HV-1219
- Status last verified
- Mar 2015
- First submitted
- 28 Aug 2013
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193
- ClinicalTrials.gov ID
- NCT01933763
- Acronym / sponsor ID
- R1193-HV-1219
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Sep 2013 (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.
Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: REGN1193, Other: PlaceboParticipants in Group A will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. |
| Group B | Experimental | Drug: REGN1193, Other: PlaceboParticipants in Group B will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men and women 18 to 45 years of age (inclusive)
- Body mass index 18.0 to 30.0 kg/m^2 (inclusive)
- Normal standard 12-lead ECG
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key exclusion criteria (11 listed)
- Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
- History of drug or alcohol abuse within a year prior to the screening visit
- Current regular smoking, or a history of smoking greater than ½ pack
- Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subject's participation in this 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 |
|---|---|---|
| REGN1193 | Drug | Group A, Group B |
| Placebo | Other | Group A, Group B |
Primary outcome
Number of TEAEs
Time frame: day 1 to day 106
The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.
1 secondary outcome
Serum concentration
Time frame: day 1 to day 106
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 13 Mar 2015.
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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 REGN1193 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 6 inclusion and 11 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 13 Mar 2015. 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?
Number of TEAEs (time frame: day 1 to day 106). 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 13 Mar 2015.