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

NCT02107872 | Completed Phase 1

• 1 other identifier: R1500-CL-1321
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Metabolic Disorders

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Serum concentration

  visit 1 to day 183

Study Arms (5)

dosing cohort 1

EXPERIMENTAL

Patients will receive REGN1500 or placebo in dosing cohort 1

Drug: REGN1500; Drug: placebo

dosing cohort 2

EXPERIMENTAL

Patients will receive REGN1500 or placebo in dosing cohort 2

Drug: REGN1500; Drug: placebo

dosing cohort 3

EXPERIMENTAL

Patients will receive REGN1500 or placebo in dosing cohort 3

Drug: REGN1500; Drug: placebo

dosing cohort 4

EXPERIMENTAL

Patients will receive REGN1500 or placebo in dosing cohort 4

Drug: REGN1500; Drug: placebo

dosing cohort 5

EXPERIMENTAL

Patients will receive REGN1500 or placebo in dosing cohort 5

Drug: REGN1500; Drug: placebo

Interventions

REGN1500 DRUG

dosing cohort 1; dosing cohort 2; dosing cohort 3; dosing cohort 4; dosing cohort 5

placebo DRUG

dosing cohort 1; dosing cohort 2; dosing cohort 3; dosing cohort 4; dosing cohort 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (4)

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (1)

• Ahmad Z, Banerjee P, Hamon S, Chan KC, Bouzelmat A, Sasiela WJ, Pordy R, Mellis S, Dansky H, Gipe DA, Dunbar RL. Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia. Circulation. 2019 Aug 6;140(6):470-486. doi: 10.1161/CIRCULATIONAHA.118.039107. Epub 2019 Jun 27.

  PMID: 31242752 DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Interventions

evinacumab

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

US (4)