Baltimore, Maryland, United States
NCT Number: NCT01015027
Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers
This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.
Looking for future studies?
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.
Inclusion criteria
- Male or female 18 to 65 years of age.
- Weight > 50 kg and < 120 kg.
- 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.
- Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
- 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.
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- Able to read, understand and willing to sign the informed consent form.
Exclusion criteria
- Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
- Pregnant or breast-feeding women.
- 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.
- Hospitalization for any reason within 60 days of screening (visit 1).
- 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).
- Previous exposure to any therapeutic or investigational biological agent. results.
- History of alcohol or substance abuse within previous 5 years.
Treatment and study plan
REGN668
Biological4 IV Cohorts (Dose 1, 2, 3, & 4)
Primary outcomes
-
The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN668 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 85/visit 11.
Time frame: 85 days
Secondary outcomes
-
Pharmacokinetics: Serum concentrations of REGN668 over time.
Time frame: 85 days
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Collaborators
- Sanofi
Registry information
Official study title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study of the Safety and Tolerability of Intravenously Administered REGN668 in Healthy Volunteers
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Nov 17, 2009
- Registry last updated
- Jun 17, 2013
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan
NCT06702423
Healthy
London, United Kingdom
View Trial DetailsValidation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNormative Value for Navicular Drop Test in Older Adults
NCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details