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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02943239