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Trial record 3 of 3 for:    regn2477

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02943239
First Posted: October 24, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
Assess the safety and tolerability of REGN2477 alone and combined with REGN1033 in health postmenopausal women.

Condition Intervention Phase
Healthy Volunteers Drug: REGN1033 Drug: REGN2477 Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacodynamics Effects of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From baseline to week 16 ]
    Incidence and severity of treatment-emergent adverse events (TEAEs)


Secondary Outcome Measures:
  • Percent change in thigh muscle volume as measured by MRI [ Time Frame: From baseline to week 8 ]
    Percent change in thigh muscle volume as measured by MRI

  • Change in thigh muscle volume as measured by MRI [ Time Frame: From baseline to week 8 ]
    Change in thigh muscle volume as measured by MRI

  • Percent change in total and regional body composition as measured by DXA [ Time Frame: From baseline to week 8 ]
    Percent change in total and regional body composition as measured by DXA

  • Change in total body composition as measured by DXA [ Time Frame: From baseline to week 8 ]
    Change in total body composition as measured by DXA

  • Change in regional body composition as measured by DXA [ Time Frame: From baseline to week 8 ]
    Change in regional body composition as measured by DXA

  • Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time [ Time Frame: From baseline to week 16 ]
    Pharmacokinetic profile of REGN2477

  • Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime [ Time Frame: From baseline to week 16 ]
    Pharmacokinetic profile of REGN1033

  • Change in total Activin A levels in blood [ Time Frame: From baseline to week 16 ]
    Change in total Activin A levels in blood

  • Change in total GDF8 levels in blood [ Time Frame: From baseline to week 16 ]
    Change in total GDF8 levels in blood

  • Presence or absence of antibodies against REGN2477 and REGN1033 [ Time Frame: From baseline to week 16 ]
    Presence or absence of antibodies against REGN2477 and REGN1033


Enrollment: 48
Actual Study Start Date: December 7, 2016
Estimated Study Completion Date: October 5, 2018
Estimated Primary Completion Date: May 14, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A
REGN1033 + REGN2477 (Regimen 1) or placebo
Drug: REGN1033
REGN1033
Drug: REGN2477
REGN2477
Other: Placebo
Placebo
Experimental: Panel B
Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo
Drug: REGN1033
REGN1033
Drug: REGN2477
REGN2477
Other: Placebo
Placebo
Experimental: Panel C
Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo
Drug: REGN1033
REGN1033
Drug: REGN2477
REGN2477
Other: Placebo
Placebo
Experimental: Panel D
Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo
Drug: REGN1033
REGN1033
Drug: REGN2477
REGN2477
Other: Placebo
Placebo

Detailed Description:

Assess the safety and tolerability of REGN2477 alone and combined with REGN1033 in health postmenopausal women.

Effect of REGN2477 alone, REGN1033 alone and REGN2477+REGN1033 in combination on muscle and body composition.

Measure amount of REGN2477 and REGN1033 in blood.

Assess presence or absence of antibodies for REGN2477 or REGN1033.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women age 45 to 70 years
  • 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

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)
  • Patients treated with a biologic therapy or biologic immunotherapy in the previous 12 weeks prior to screening and during the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943239


Locations
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02943239     History of Changes
Other Study ID Numbers: R2477-1033-HV-1621
2016-002979-95 ( EudraCT Number )
First Submitted: October 19, 2016
First Posted: October 24, 2016
Last Update Posted: November 6, 2017
Last Verified: November 2017