Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786)

NCT01720576 | Completed Phase 1

• 1 other identifier: R1033-HV-1204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is a study to assess the safety and tolerability of subcutaneously administered REGN1033 (SAR391786) in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of TEAEs

  The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study).

  Day 1 to Day 141

Secondary Outcomes (2)

• Serum concentration of REGN1033 (SAR391786)

  Day 1 to Day 141

• immunogenicity

  Day 1 to Day 141

Study Arms (3)

Cohort 1

EXPERIMENTAL

Dose 1 of REGN1033 (SAR391786) or Placebo

Drug: REGN1033 (SAR391786); Drug: Placebo

Cohort 2

EXPERIMENTAL

Dose 2 of REGN1033 (SAR391786) or Placebo

Drug: REGN1033 (SAR391786); Drug: Placebo

Cohort 3

EXPERIMENTAL

Dose 3 of REGN1033 (SAR391786) or Placebo

Drug: REGN1033 (SAR391786); Drug: Placebo

Interventions

REGN1033 (SAR391786) DRUG

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
• Sexually active males willing to use contraceptives during the study and through 4 months after the study.
• Female subjects not of child bearing potential (surgically sterile or postmenopausal for longer than 1 year)
• Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive
• Willing to maintain current diet and exercise routine for the duration of the study
• Willing and able to return for all clinic visits and complete all study-related procedures
• Able to read and understand, and willing to sign the ICF

You may not qualify if:

• Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
• Evidence of malnutrition
• Cachexia of any cause
• Evidence or history of muscle diseases or weakness with the exception of age related muscle loss
• Limb amputation
• Immobilization, surgical procedure, fracture, or trauma to the upper or lower limb within 6 months
• History or evidence of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure (New York Heart Association \[NYHA\] stage 2-4), cardiac arrhythmia with clinical symptoms, valvular heart disease, and cardiac hypertrophy of clinical significance
• Women of childbearing potential (not surgically sterile or amenorrheic for at least 12 months if postmenopausal)
• Uncontrolled diabetes defined as HbA1C \> 7.5 at screening; if taking oral hypoglycemic drugs, have to be on stable doses of medication for more than 3 months. Diabetics using insulin are excluded
• Asthmatic subjects with current or recurring symptoms within 1 year.
• History of, COPD, chronic kidney disease, cancer except primary basal-cell skin cancer that has been adequately treated
• Neurological injury (eg, stroke) within 1 year
• Abnormal or uncontrolled blood pressure at screening visit defined as diastolic BP \>95 and/or systolic BP \>160 mm Hg; if taking hypertensive medication, have to be on stable doses of medication for more than 3 months
• Hepatic transaminases (ALT and or AST) \> 2X ULN
• Reduced renal function as defined by eGFR\<60 mL/min

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (2)

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Evansville, Indiana, 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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (2)