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

Primary Purpose

Hypertriglyceridemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

REGN1500

placebo

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

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

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A: Cohorts 1 through 6

Group B

Group C: Cohorts 1 and 2

Arm Description

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

Group B will receive REGN1500 IV or placebo

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum concentration of REGN1500

Serum concentration of REGN1500 over time (summary statistics and PK parameters)

Full Information

NCT ID

NCT01749878

First Posted

December 12, 2012

Last Updated

May 10, 2016

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01749878

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: Cohorts 1 through 6

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

Group B will receive REGN1500 IV or placebo

Arm Title

Group C: Cohorts 1 and 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

REGN1500

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Safety

Description

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.

Time Frame

Day 1 to Day 106/126

Secondary Outcome Measure Information:

Title

Serum concentration of REGN1500

Description

Serum concentration of REGN1500 over time (summary statistics and PK parameters)

Time Frame

Day 1 to Day 106/126

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 (The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Philadelphia

State/Province

Pennsylvania

Country

United States

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31242752

Citation

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. Erratum In: Circulation. 2021 Mar 30;143(13):e799.

Results Reference

derived

PubMed Identifier

28538136

Citation

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.

Results Reference

derived

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

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