Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | March 2016 |
End Date: | June 2016 |
Contact: | Clinical Trials Administrator |
Email: | clinicaltrials@regeneron.com |
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.
Secondary Objective: Assess safety and tolerability of REGN1033.
Key Inclusion Criteria:
1. Healthy males and females (not of childbearing potential) between the ages of 18 and
65 years
2. Body weight between 50.0 kg and 95.0 kg
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent
Key Exclusion Criteria:
1. 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
2. Hemoglobin not within normal limits
3. Positive drug and alcohol screen test results at screening visits 1 and 2
4. Low or elevated blood pressure and/or heart rate after 3 minutes resting in the
seated position:
5. Recent use (within 3 months prior to screening) of androgenic steroids
6. 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
7. Previous exposure to any biological therapeutic agent, except vaccines
8. Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
9. Pregnant or breastfeeding women, and women of childbearing potential
10. Sexually active men who are unwilling to practice adequate contraception during the
study
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