A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477

NCT02870400 | Completed Phase 1

• 1 other identifier: R2477-HV-1525
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477

  Day 1 to Day 113

Secondary Outcomes (2)

• Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time

  Day 1 to Day 113

• Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time

  Day 1 to Day 113

Study Arms (2)

REGN2477

EXPERIMENTAL

Cohorts 1 - 5 will receive REGN2477

Drug: REGN2477

Placebo

EXPERIMENTAL

Cohorts 1 - 5 will receive placebo

Drug: Placebo

Interventions

REGN2477 DRUG

Participants will receive ascending doses of REGN2477

REGN2477

Placebo DRUG

Participants will receive matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
• A body mass index (BMI) between 18 to 30 kg/m2, inclusive
• Provide a signed informed consent

You may not qualify if:

• Significant illness or history of significant illness
• Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
• Current smoker or former smoker who has stopped smoking within 3 months prior to screening
• Positive urine drug test results during screening, or history of drug or alcohol abuse
• Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
• History of diabetes
• Abnormal blood pressure (BP)
• History of gynecological disorders or malignancies; history of breast malignancies; or history of benign gynecological or breast lesions that require medical treatment or follow up
• Reduced renal function
• Known history of chronic hepatitis or HIV
• Clinically significant ECG abnormalities
• Participation in any clinical research study within 30 days, or 5 halflives, of the study drug, whichever is greater, or for longer periods per regional requirements, prior to the screening visit
• Exposure to any biological drugs within 3 months of the screening visit (the name of the drug and duration of previous exposure will be recorded). Vaccination within 4 weeks of screening visit.
• History of hypersensitivity reactions to vaccines or other biologics
• History of hypersensitivity to doxycycline or other tetracycline antibiotics

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: July 1, 2016
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

BE (1)