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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02870400
• Date of registration: 12/08/2016
• Prospective Registration: No
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
• Scientific 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
• Date of first enrolment: July 2016
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02870400
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Placebo

Drug: REGN2477

Primary Outcome(s)

Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477 [Time Frame: Day 1 to Day 113]

Secondary Outcome(s)

Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time [Time Frame: Day 1 to Day 113]

Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time [Time Frame: Day 1 to Day 113]

Secondary ID(s)

R2477-HV-1525

Source(s) of Monetary Support

Please refer to primary and secondary sponsors