NCT Number: NCT02107872
Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.
Looking for future studies?
Notify MeKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Daytona Beach, Florida, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Provide signed informed consent
- Otherwise healthy men and women ages 18 to 65 years, inclusive
- Body mass index of 18.0 kg/m2to 38.0 kg/m2, inclusive
- Normal standard 12-lead ECG
- Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit
- Willing to consistently maintain his/her usual diet for the duration of the study
- Willing to refrain from strenuous exercise for the duration of the trial
- Willing and able to comply with clinic visits and study-related procedures
- 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 the full duration of the study.
Exclusion criteria
- Any clinically significant abnormalities observed during the screening visit
- History of drug or alcohol abuse within 1 year of screening
- Receipt of 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.
- 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 subjects 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
- Hospitalization for any reason within 60 days of screening
- History or presence of malignancy within 5 years prior to the screening visit (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix
- Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
- 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
Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Safety
Time frame: visit 1 to day 183 (EOS)
Safety of REGN1500 will be assessed by physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations from visit 1 to day 183 [EOS (end of study)]
Secondary outcomes
-
Serum concentration
Time frame: visit 1 to day 183
Serum concentration, amount of REGN1500 in the circulation, over time (visit 1 to day 183)
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 8, 2014
- Registry last updated
- Sep 30, 2015
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.
Effect of NAE on Polycystic Ovarian Syndrome (PCOS)
NCT07603505
Adnexal Diseases, Cysts
Karachi, Sindh, Pakistan
View Trial DetailsSafety and Effectiveness of Overripe Banana Powder Added to Diabetic Formulas in Type 2 Diabetes
NCT07471607
Diabetes Mellitus, Diabetes Mellitus, Type 2
Kubang Kerian, Kelantan, Malaysia
View Trial DetailsPost-delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention
NCT06067126
Body Weight, Metabolic Diseases
Portland, Oregon, United States
View Trial DetailsConcurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress
NCT04868240
Behavior, Concurrent Exercise
Coimbra, Portugal
View Trial Details