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

Regeneron Pharmaceuticals logo

Regeneron Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: REGN1033
Drug: REGN2477
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02943239
2016-002979-95 (EudraCT Number)
R2477-1033-HV-1621

Details and patient eligibility

About

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

Enrollment

82 patients

Sex

All

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

82 participants in 7 patient groups

Panel A
Experimental group
Description:
REGN1033 + REGN2477 (Regimen 1) or placebo
Treatment:
Other: Placebo
Drug: REGN2477
Drug: REGN1033
Panel B
Experimental group
Description:
Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo
Treatment:
Other: Placebo
Drug: REGN2477
Drug: REGN1033
Panel C
Experimental group
Description:
Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo
Treatment:
Other: Placebo
Drug: REGN2477
Drug: REGN1033
Panel D
Experimental group
Description:
Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo
Treatment:
Other: Placebo
Drug: REGN2477
Drug: REGN1033
Panel E
Experimental group
Description:
REGN2477 (Regimen 5) or placebo
Treatment:
Other: Placebo
Drug: REGN2477
Panel F
Experimental group
Description:
REGN2477 + REGN1033 (Regimen 6) or placebo
Treatment:
Other: Placebo
Drug: REGN2477
Drug: REGN1033
Panel G
Experimental group
Description:
REGN2477 (Regimen 7) or placebo
Treatment:
Other: Placebo
Drug: REGN2477

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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