Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943239
• Other study ID #: R2477-1033-HV-1621
• Secondary ID: 2016-002979-95
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2016
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2019
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033.

The secondary objectives are to:

• Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume

• Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition

• Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033

• Assess immunogenicity of REGN2477 or REGN1033

• Assess REGN2477 or REGN1033 target engagement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Postmenopausal women age 45 to 70 years and age 35 to 60 years inclusive for men not intending to father children

• BMI between 18 to 32 kg/m2, inclusive

• Willing and able to maintain current diet, supplements and physical activity level throughout the study

• Provides signed informed consent

Key Exclusion Criteria:

• Significant illness or history of significant illness

• Contraindication to MRI

• History of human immunodeficiency virus (HIV); hepatitis B or hepatitis C virus (HCV)

• History of immobilization, major surgical procedure, fracture, or major trauma within 9 months prior to screening

• History of significant gynecological disorders or malignancies; history of breast malignancies (uterine fibroids or dysfunctional uterine bleeding is acceptable)

• Inconsistent vigorous physical activity (on fewer than 5 days per week), such as intermittent weight lifting

• History of hypersensitivity reactions to tetracycline antibiotics (includes doxycycline), vaccines, or biologics

• Use of agents that alter muscle mass that have not been at a stable dose for 3 months prior to screening (includes protein supplements), or use of any weight altering or anabolic steroid drugs (includes drugs for obesity, diuretics, testosterone)

• Participants treated with a biologic therapy or biologic immunotherapy in the previous 12 weeks prior to screening and during the study

Note: Other protocol Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN1033
REGN1033
• REGN2477
REGN2477

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment-emergent adverse events (TEAEs)		Up to 40 weeks
Secondary	Percent change in thigh muscle volume as measured by MRI		Up to 28 weeks
Secondary	Change in thigh muscle volume as measured by MRI		Up to 28 weeks
Secondary	Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)		Up to 28 weeks
Secondary	Change in total body composition as measured by DXA		Up to 28 weeks
Secondary	Change in regional body composition as measured by DXA		Up to 28 weeks
Secondary	Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time		Up to 40 weeks
Secondary	Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime		Up to 40 weeks
Secondary	Change in total Activin A levels in blood		Up to 40 weeks
Secondary	Change in total GDF8 levels in blood		Up to 32 weeks
Secondary	Presence or absence of antibodies against REGN2477 and REGN1033		Up to 40 weeks