Clinical trial NCT02943239: Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 40 weeks
Secondary outcomes:
measure: Percent change in thigh muscle volume as measured by MRI
timeFrame: Up to 28 weeks
measure: Change in thigh muscle volume as measured by MRI
timeFrame: Up to 28 weeks
measure: Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)
timeFrame: Up to 28 weeks
measure: Change in total body composition as measured by DXA
timeFrame: Up to 28 weeks
measure: Change in regional body composition as measured by DXA
timeFrame: Up to 28 weeks
measure: Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time
timeFrame: Up to 40 weeks
measure: Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime
timeFrame: Up to 40 weeks
measure: Change in total Activin A levels in blood
timeFrame: Up to 40 weeks
measure: Change in total GDF8 levels in blood
timeFrame: Up to 32 weeks
measure: Presence or absence of antibodies against REGN2477 and REGN1033
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: