Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers

NCT02121080 | Completed Phase 1

• 1 other identifier: R2222-HV-1326
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in cohorts of healthy adult volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.

  from day 1 up to week 20 (EOS)

Secondary Outcomes (2)

• Serum concentration

  from day 1 over time up to week 20

• Presence or absence of antibodies

  from day 1 over time up to week 20

Study Arms (5)

Cohort 1

EXPERIMENTAL

Dosing regimen 1

Drug: REGN2222(SAR438584); Drug: placebo

Cohort 2

EXPERIMENTAL

Dosing regimen 2

Drug: REGN2222(SAR438584); Drug: placebo

Cohort 3

EXPERIMENTAL

Dosing regimen 3

Drug: REGN2222(SAR438584); Drug: placebo

Cohort 4

EXPERIMENTAL

Dosing regimen 4

Drug: REGN2222(SAR438584); Drug: placebo

Cohort 5

EXPERIMENTAL

Dosing regimen 5

Drug: REGN2222(SAR438584); Drug: placebo

Interventions

REGN2222(SAR438584) DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

placebo DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy man or woman aged 18 to 60 years
• Body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

You may not qualify if:

• Serum hemoglobin, creatinine, alkaline phosphatase, CPK, and/or hepatic enzymes (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\], total bilirubin \[unless the investigator has evidence that increased bilirubin corresponds to a Gilbert's type syndrome with elevated indirect bilirubin\]) that is \>1.5 the upper limit of normal (ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant abnormalities from the normal range, as determined by the investigator at the screening visit
• Use of any concomitant medications within 30 days or at least 5 half-lives, whichever is longer, of the screening visit, including prescription medications (except contraceptives), nutritional supplements, and over-the-counter medications (except acetaminophen)
• Hospitalization for any reason within 60 days of the screening visit
• History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
• History of or positive blood test result for hepatitis B surface antigen and/or hepatitis C virus antibody at the screening visit
• History of autoimmune disease
• History of respiratory disease (e.g, asthma, chronic obstructive pulmonary disease)
• History of drug or alcohol abuse within 1 year prior to the screening visit
• Participation in any clinical research study evaluating another investigational drug or therapy within 30 days, or within at least 5 half-lives, of the investigational drug (whichever is longer) prior to the screening visit
• Pregnant or breastfeeding woman
• Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study, and up to 3 months after the last dose of the study drug (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
• Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Contraception is not required for women with documented hysterectomy or tubal ligation.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (3)