Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers
NCT ID: NCT01015027
Last Updated: 2013-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2009-10-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Dose 1
(3:1, active:placebo)
REGN668
4 IV Cohorts (Dose 1, 2, 3, \& 4)
Dose 2
(3:1, active:placebo)
REGN668
4 IV Cohorts (Dose 1, 2, 3, \& 4)
Dose 3
(3:1, active:placebo)
REGN668
4 IV Cohorts (Dose 1, 2, 3, \& 4)
Dose 4
(3:1, active:placebo)
REGN668
4 IV Cohorts (Dose 1, 2, 3, \& 4)
Interventions
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REGN668
4 IV Cohorts (Dose 1, 2, 3, \& 4)
Eligibility Criteria
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Inclusion Criteria
2. Weight \> 50 kg and \< 120 kg.
3. For women of childbearing potential, a negative serum pregnancy test at the screening visit (visit 1) and a negative urine pregnancy test on day -1.
4. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
5. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the full duration of the study.
6. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
7. Able to read, understand and willing to sign the informed consent form.
Exclusion Criteria
2. Pregnant or breast-feeding women.
3. 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 would adversely affect the subject's participation in this study.
4. Hospitalization for any reason within 60 days of screening (visit 1).
5. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C, and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV).
6. Previous exposure to any therapeutic or investigational biological agent. results.
7. History of alcohol or substance abuse within previous 5 years.
18 Years
65 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Allen Radin
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Baltimore, Maryland, United States
Countries
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References
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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.
Other Identifiers
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R668-AS-0907
Identifier Type: -
Identifier Source: org_study_id
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