Study of Fasinumab (REGN475) in Healthy Japanese and Caucasian Subjects

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02516618
• Other study ID #: R475-PN-1516
• Status: Recruiting
• Phase: Phase 1
• First received: July 31, 2015
• Last updated: August 3, 2015
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Key Inclusion Criteria:

1. Healthy male or female Japanese and Caucasian volunteers =20 and =55 years of age at the screening visit

2. Japanese subjects must:

• Be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese

• Have maintained a Japanese lifestyle since leaving Japan

3. Caucasian subjects must be Caucasian of European or Latin American descent

4. Have a Body Mass Index (BMI) = 35

5. Be willing to refrain from taking NSAID medications (oral or topical) for 1 week prior to receiving study drug and for 16 weeks after study drug administration

Key Exclusion Criteria:

1. History or presence at the screening visit of bone or joint disorders including but not limited to osteoarthritis, avascular necrosis, destructive arthropathy, pathologic fractures, osteonecrosis, rheumatoid arthritis, neuropathic joint arthropathy, lupus erythematosus, or inflammatory joint diseases

2. History of joint-related events such as, but not limited to, total joint replacement (TJR) surgery, patella dislocation, hip dislocation, knee dislocation, injury to meniscus or knee ligaments (with or without surgical repair), or joint infections

3. Trauma to any joint in the 30 days prior to the screening visit

4. History of autonomic neuropathy, or diabetic neuropathy

5. Evidence of autonomic neuropathy

6. Presence of clinically relevant peripheral neuropathy

7. History or presence at the screening visit of orthostatic hypotension

8. History or evidence at screening of heart block

9. Resting heart rate of <50 or >100 beats per minute (bpm)

10. History of poorly controlled hypertension:

11. Congestive heart failure with NY Heart Classification of stage 3 or 4

12. History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit

13. Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/PK data

14. HIV, hepatitis B, or hepatitis C positive by serological testing at the screening visit

15. History or presence of malignancy within 5 years prior to screening, except subjects who have been treated successfully with no recurrence of basal or squamous cell carcinoma of the skin (< 1 year), in situ cervical cancer, or in situ ductal breast cancer

16. Women of reproductive potential who have a positive serum pregnancy test result at the screening visit, or a positive urine pregnancy test result at the baseline visit, or who do not have their pregnancy test results at the baseline visit

17. Pregnant or breast-feeding women

18. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug, whichever is longer, prior to the day 1 visit

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Fasinumab

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.		Baseline to week 16 (End of Study)	Yes
Secondary	Fasinumab serum concentrations over time		Baseline to week 16 (End of Study)	No
Secondary	Presence of anti-fasinumab antibodies over time		Baseline to week 16 (End of Study)	No