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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02943239




Registration number
NCT02943239
Ethics application status
Date submitted
19/10/2016
Date registered
24/10/2016
Date last updated
9/08/2024

Titles & IDs
Public title
Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
Scientific 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
Secondary ID [1] 0 0
2016-002979-95
Secondary ID [2] 0 0
R2477-1033-HV-1621
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - REGN1033
Treatment: Drugs - REGN2477
Other interventions - Placebo

Experimental: Panel A - REGN1033 + REGN2477 (Regimen 1) or placebo

Experimental: Panel B - Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo

Experimental: Panel C - Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo

Experimental: Panel D - Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo

Experimental: Panel E - REGN2477 (Regimen 5) or placebo

Experimental: Panel F - REGN2477 + REGN1033 (Regimen 6) or placebo

Experimental: Panel G - REGN2477 (Regimen 7) or placebo


Treatment: Drugs: REGN1033
REGN1033

Treatment: Drugs: REGN2477
REGN2477

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 40 weeks
Secondary outcome [1] 0 0
Percent change in thigh muscle volume as measured by MRI
Timepoint [1] 0 0
Up to 28 weeks
Secondary outcome [2] 0 0
Change in thigh muscle volume as measured by MRI
Timepoint [2] 0 0
Up to 28 weeks
Secondary outcome [3] 0 0
Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)
Timepoint [3] 0 0
Up to 28 weeks
Secondary outcome [4] 0 0
Change in total body composition as measured by DXA
Timepoint [4] 0 0
Up to 28 weeks
Secondary outcome [5] 0 0
Change in regional body composition as measured by DXA
Timepoint [5] 0 0
Up to 28 weeks
Secondary outcome [6] 0 0
Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time
Timepoint [6] 0 0
Up to 40 weeks
Secondary outcome [7] 0 0
Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime
Timepoint [7] 0 0
Up to 40 weeks
Secondary outcome [8] 0 0
Change in total Activin A levels in blood
Timepoint [8] 0 0
Up to 40 weeks
Secondary outcome [9] 0 0
Change in total GDF8 levels in blood
Timepoint [9] 0 0
Up to 32 weeks
Secondary outcome [10] 0 0
Presence or absence of antibodies against REGN2477 and REGN1033
Timepoint [10] 0 0
Up to 40 weeks

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2019
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT02943239
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02943239