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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02516618

Collaborator

(none)

Enrollment

Location

Arms

7.1

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Fasinumab Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Participants in this cohort will receive dose 1 of Fasinumab or placebo	Drug: Fasinumab Other Names: REGN475 Drug: Placebo
Experimental: Cohort 2 Participants in this cohort will receive dose 2 of Fasinumab or placebo	Drug: Fasinumab Other Names: REGN475 Drug: Placebo
Experimental: Cohort 3 Participants in this cohort will receive dose 3 of Fasinumab or placebo	Drug: Fasinumab Other Names: REGN475 Drug: Placebo
Experimental: Cohort 4 Participants in this cohort will receive dose 4 of Fasinumab or placebo	Drug: Fasinumab Other Names: REGN475 Drug: Placebo
Experimental: Cohort 5 Participants in this cohort will receive dose 5 of Fasinumab or placebo	Drug: Fasinumab Other Names: REGN475 Drug: Placebo

Outcome Measures

Primary Outcome Measures

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)]

Secondary Outcome Measures

Fasinumab serum concentrations over time [Baseline to week 16 (End of Study)]
Presence of anti-fasinumab antibodies over time [Baseline to week 16 (End of Study)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Healthy male or female Japanese and Caucasian volunteers ≥20 and ≤55 years of age at the screening visit
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

Caucasian subjects must be Caucasian of European or Latin American descent
Have a Body Mass Index (BMI) ≤ 35
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:

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
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
Trauma to any joint in the 30 days prior to the screening visit
History of autonomic neuropathy, or diabetic neuropathy
Evidence of autonomic neuropathy
Presence of clinically relevant peripheral neuropathy
History or presence at the screening visit of orthostatic hypotension
History or evidence at screening of heart block
Resting heart rate of <50 or >100 beats per minute (bpm)
History of poorly controlled hypertension:
Congestive heart failure with NY Heart Classification of stage 3 or 4
History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit
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
HIV, hepatitis B, or hepatitis C positive by serological testing at the screening visit
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
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
Pregnant or breast-feeding women
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Glendale	California	United States

Sponsors and Collaborators

Regeneron Pharmaceuticals

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:

NCT02516618

Other Study ID Numbers:

R475-PN-1516

First Posted:

Aug 6, 2015

Last Update Posted:

May 12, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Fasinumab

Study Results

No Results Posted as of May 12, 2016