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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01507402
• Collaborator: Sanofi (Industry)
• Enrollment: 76
• Locations: 2
• Arms: 9
• Duration (Months): 10
• Patients Per Site: 38
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: REGN1033(SAR391786); Drug: REGN1033(SAR391786); Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Dose regimen 1 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: Placebo; (inactive substance)
Experimental: Cohort 2 Dose regimen 2 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: Placebo; (inactive substance)
Experimental: Cohort 3 Dose regimen 3 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: Placebo; (inactive substance)
Experimental: Cohort 4 Dose regimen 4 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: Placebo; (inactive substance)
Experimental: Cohort 5 Dose regimen 5 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
Experimental: Cohort 6 Dose regimen 6 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
Experimental: Cohort 7 Dose regimen 7 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method B; Drug: Placebo; (inactive substance)
Experimental: Cohort 8 Dose regimen 3 (Participants > 65 to ≤ 85 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: Placebo; (inactive substance)
Experimental: Cohort 9 Dose regimen 9 (Participants 18 to ≤ 65 yrs old)	Drug: REGN1033(SAR391786); Administration method A; Drug: Placebo; (inactive substance)

Outcome Measures

Primary Outcome Measures

1. Number of TEAEs [Day 1 to Day 113]

   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).

Secondary Outcome Measures

1. Serum concentration [Baseline to End of Study (Day 113)]

   To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033.

2. Immunogenicity [Baseline to End of Study (Day 113)]

   To assess the potential for immunogenicity following IV and SC doses of REGN1033.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Honolulu	Hawaii	United States
2		Evansville	Indiana	United States	47710

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01507402
• Other Study ID Numbers: R1033-HV-1107
• First Posted: Jan 10, 2012
• Last Update Posted: Nov 14, 2012
• Last Verified: Nov 1, 2012

Study Results

No Results Posted as of Nov 14, 2012