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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720576
• Other study ID #: R1033-HV-1204
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2012
• Last updated: September 10, 2013
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.

A subject must meet the following criteria to be eligible for inclusion in the study:

1. Sexually active males willing to use contraceptives during the study and through 4 months after the study.

2. Female subjects not of child bearing potential (surgically sterile or postmenopausal for longer than 1 year)

3. Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive

4. Willing to maintain current diet and exercise routine for the duration of the study

5. Willing and able to return for all clinic visits and complete all study-related procedures

6. Able to read and understand, and willing to sign the ICF

Exclusion Criteria:

1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.

2. Evidence of malnutrition

3. Cachexia of any cause

4. Evidence or history of muscle diseases or weakness with the exception of age related muscle loss

5. Limb amputation

6. Immobilization, surgical procedure, fracture, or trauma to the upper or lower limb within 6 months

7. 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

8. Women of childbearing potential (not surgically sterile or amenorrheic for at least 12 months if postmenopausal)

9. 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

10. Asthmatic subjects with current or recurring symptoms within 1 year.

11. History of, COPD, chronic kidney disease, cancer except primary basal-cell skin cancer that has been adequately treated

12. Neurological injury (eg, stroke) within 1 year

13. 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

14. Hepatic transaminases (ALT and or AST) > 2X ULN

15. Reduced renal function as defined by eGFR<60 mL/min

16. Current smokers or previous smokers who stopped smoking within 6 months

17. Current or recent history (within 1 year of screen) of alcohol or drug abuse

18. History of hypersensitivity response to any biologics

19. History of hypersensitivity to doxycycline or other tetracycline antibiotics

20. Current or recent participation in any clinical trial (within 30 days of small molecular drugs or within 3 months of biologics)

21. Exposure within 3 months to approved biological drugs. (The name of the drug and duration of previous exposure will be recorded). Vaccines are allowed.

22. Sexually active men* who are unwilling to practice adequate contraception during the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN1033 (SAR391786)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Serum concentration of REGN1033 (SAR391786)	Serum concentration of REGN1033 (SAR391786) over time	Day 1 to Day 141	No
Secondary	immunogenicity	Presence or absence of anti-REGN1033 (SAR391786) antibodies over time (immunogenicity )	Day 1 to Day 141	No