San Antonio, Texas, United States
NCT Number: NCT02741739
Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects
Primary Objective: Determine blood concentrations of two formulations of REGN1033.
Secondary Objective: Assess safety and tolerability of REGN1033.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
- Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years
- Body weight between 50.0 kg and 95.0 kg
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key Exclusion Criteria:
- 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
- Hemoglobin not within normal limits
- Positive drug and alcohol screen test results at screening visits 1 and 2
- Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
- Recent use (within 3 months prior to screening) of androgenic steroids
- 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
- Previous exposure to any biological therapeutic agent, except vaccines
- Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
- Pregnant or breastfeeding women, and women of childbearing potential
- Sexually active men who are unwilling to practice adequate contraception during the study
Treatment and study plan
REGN1033
DrugPrimary outcomes
-
Serum REGN1033 concentration-time curve (AUC)
Time frame: Pre-dose to day 57
-
Peak REGN1033 concentration (Cmax)
Time frame: Pre-dose to day 57
Secondary outcomes
-
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Time frame: Day 1 to end of study (Day 57)
-
Presence or absence of anti-drug antibody (ADA)
Time frame: Day 1 to end of study (Day 57)
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Apr 18, 2016
- Registry last updated
- Oct 14, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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