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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870400
• Other study ID #: R2477-HV-1525
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2016
• Last updated: February 16, 2017
• Start date: July 2016
• Est. completion date: January 12, 2017

Study information

• Verified date: February 2017
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN2477
Participants will receive ascending doses of REGN2477
• Placebo
Participants will receive matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477		Day 1 to Day 113
Secondary	Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time		Day 1 to Day 113
Secondary	Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time		Day 1 to Day 113