Study to Assess the Safety and Tolerability of Single Doses of REGN1500

NCT01749878 | Completed Phase 1

• 1 other identifier: R1500-HV-1214
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of REGN1500

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Safety

  The primary endpoint in the study is the incidence and severity of treatment-emergent adverse events (TEAEs) through day 106/126 in participants treated with REGN1500.

  Day 1 to Day 106/126

Secondary Outcomes (1)

• Serum concentration of REGN1500

  Day 1 to Day 106/126

Study Arms (3)

Group A: Cohorts 1 through 6

EXPERIMENTAL

Group A: Cohorts 1 through 3 will receive REGN1500 subcutaneous (SC) or placebo Cohorts 4 through 6 will receive REGN1500 intravenous (IV) or placebo

Drug: REGN1500; Drug: placebo

Group B

EXPERIMENTAL

Group B will receive REGN1500 IV or placebo

Drug: REGN1500; Drug: placebo

Group C: Cohorts 1 and 2

EXPERIMENTAL

Group C: Cohort 1 will receive REGN1500 SC or placebo Cohort 2 will receive REGN1500 IV or placebo

Drug: REGN1500; Drug: placebo

Interventions

REGN1500 DRUG

Group A: Cohorts 1 through 6; Group B; Group C: Cohorts 1 and 2

placebo DRUG

Group A: Cohorts 1 through 6; Group B; Group C: Cohorts 1 and 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index 18.0 to 40.0 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
• Provide signed informed consent
• For sexually active men and women, willingness to utilize adequate contraception and not 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 (2)

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Related Publications (2)

• 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

• Dewey FE, Gusarova V, Dunbar RL, O'Dushlaine C, Schurmann C, Gottesman O, McCarthy S, Van Hout CV, Bruse S, Dansky HM, Leader JB, Murray MF, Ritchie MD, Kirchner HL, Habegger L, Lopez A, Penn J, Zhao A, Shao W, Stahl N, Murphy AJ, Hamon S, Bouzelmat A, Zhang R, Shumel B, Pordy R, Gipe D, Herman GA, Sheu WHH, Lee IT, Liang KW, Guo X, Rotter JI, Chen YI, Kraus WE, Shah SH, Damrauer S, Small A, Rader DJ, Wulff AB, Nordestgaard BG, Tybjaerg-Hansen A, van den Hoek AM, Princen HMG, Ledbetter DH, Carey DJ, Overton JD, Reid JG, Sasiela WJ, Banerjee P, Shuldiner AR, Borecki IB, Teslovich TM, Yancopoulos GD, Mellis SJ, Gromada J, Baras A. Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease. N Engl J Med. 2017 Jul 20;377(3):211-221. doi: 10.1056/NEJMoa1612790. Epub 2017 May 24.

  PMID: 28538136 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

evinacumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (2)