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

NCT ID: NCT02870400

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-01-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

REGN2477

Cohorts 1 - 5 will receive REGN2477

Group Type: EXPERIMENTAL

REGN2477

Intervention Type: DRUG

Participants will receive ascending doses of REGN2477

Placebo

Cohorts 1 - 5 will receive placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive matching placebo

Interventions

REGN2477

Participants will receive ascending doses of REGN2477

Intervention Type: DRUG

Placebo

Participants will receive matching placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings

2. A body mass index (BMI) between 18 to 30 kg/m2, inclusive

3. Provide a signed informed consent

Exclusion Criteria

1. Significant illness or history of significant illness

2. Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening

3. Current smoker or former smoker who has stopped smoking within 3 months prior to screening

4. Positive urine drug test results during screening, or history of drug or alcohol abuse

5. Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening

6. History of diabetes

7. Abnormal blood pressure (BP)

8. 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

9. Reduced renal function

10. Known history of chronic hepatitis or HIV

11. Clinically significant ECG abnormalities

12. 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

13. 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.

14. History of hypersensitivity reactions to vaccines or other biologics

15. History of hypersensitivity to doxycycline or other tetracycline antibiotics

16. History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab

17. Subject using hormone replacement therapy or thyroid replacement therapy will be excluded, unless they have been on stable doses of such therapy for at least 6 months and will remain on the same stable dose through the duration of the trial

18. Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

R2477-HV-1525

Identifier Type: -

Identifier Source: org_study_id