Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500

Metabolic Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107872
• Other study ID #: R1500-CL-1321
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2014
• Last updated: September 28, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolic Disorders

Intervention

Drug:
• REGN1500

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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)]	visit 1 to day 183 (EOS)	Yes
Secondary	Serum concentration	Serum concentration, amount of REGN1500 in the circulation, over time (visit 1 to day 183)	visit 1 to day 183	No