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

NCT02516618 | Completed Phase 1 DMC

• 1 other identifier: R475-PN-1516
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (5)

Cohort 1

EXPERIMENTAL

Participants in this cohort will receive dose 1 of Fasinumab or placebo

Drug: Fasinumab; Drug: Placebo

Cohort 2

EXPERIMENTAL

Participants in this cohort will receive dose 2 of Fasinumab or placebo

Drug: Fasinumab; Drug: Placebo

Cohort 3

EXPERIMENTAL

Participants in this cohort will receive dose 3 of Fasinumab or placebo

Drug: Fasinumab; Drug: Placebo

Cohort 4

EXPERIMENTAL

Participants in this cohort will receive dose 4 of Fasinumab or placebo

Drug: Fasinumab; Drug: Placebo

Cohort 5

EXPERIMENTAL

Participants in this cohort will receive dose 5 of Fasinumab or placebo

Drug: Fasinumab; Drug: Placebo

Interventions

Fasinumab DRUG

Also known as: REGN475

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

MeSH Terms

Interventions

fasinumab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 6, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)