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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507402
• Other study ID #: R1033-HV-1107
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2012
• Last updated: November 12, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• 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 randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Healthy males and postmenopausal or surgically sterile females

2. Body mass index (BMI) between 18 and 30 kg/m2 inclusive

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

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

Exclusion Criteria:

1. Significant concomitant illness or history of significant illness such as, but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic or lymphatic disease that would adversely affect the subject's participation in this study

2. History of muscle neoplasms such as rhabdomyoma, rhabdomyosarcoma, leiomyoma, leiomyosarcoma or uterine fibroid tumors

3. History of muscular dystrophy, myositis, and other primary diseases of skeletal muscle

4. History of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure, or cardiac arrhythmia, valvular heart disease or cardiac hypertrophy. Subjects taking prophylactic aspirin are excluded from the study and should not discontinue taking prophylactic aspirin to participate in the study

5. History of systemic hypertension or use of concomitant medications to treat hypertension, or history of pulmonary hypertension

6. History of diabetes mellitus or gestational diabetes or use of concomitant medications for treatment of these

7. Recent use of androgenic steroids

8. Unexplained creatine phosphokinase (CPK) levels >3X upper limit of normal.

9. 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

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

11. Onset of a new exercise routine or major change to a previous exercise or diet routine within 4 weeks prior to screening. Subjects must be willing to maintain his/her previous level of exercise for the duration of the study

12. Known history of seropositivity to human immunodeficiency virus (HIV) antibody; hepatitis B surface antigen or hepatitis C antibody (HCV) associated with a positive HCV RNA polymerase chain reaction at the screening visit

13. Positive urine drug test results during screening or history of drug or alcohol abuse within a year prior to the screening visit

14. Any hospitalization within 60 days prior to the screening visit

15. Participation in any clinical research study evaluating 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

16. History of a hypersensitivity reaction to doxycycline or to other tetracycline drugs

17. Previous exposure to any biological therapeutic agent, excepting vaccines

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN1033(SAR391786)
Administration method A
• REGN1033(SAR391786)
Administration method B
• Placebo
(inactive substance)

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 subjects treated with REGN1033 or placebo, reported from the time of administration of study drug on day 1 (baseline) to completion of the study (day 113).	Day 1 to Day 113	Yes
Secondary	Serum concentration	To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033.	Baseline to End of Study (Day 113)	No
Secondary	Immunogenicity	To assess the potential for immunogenicity following IV and SC doses of REGN1033.	Baseline to End of Study (Day 113)	No