Status:
COMPLETED
A Study of ACE-2494 in Healthy Subjects
Lead Sponsor:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess safety, tolerance, pharmacokinetic, and pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women.
Detailed Description
Subjects will be evaluated for study inclusion/exclusion criteria during the screening period (within 4 weeks prior to Day -1) and eligible subjects who have signed the informed consent form (ICF) wil...
Eligibility Criteria
Inclusion
- Postmenopausal women, with menopause defined by follicle stimulating hormone (FSH) level \> 40 IU/L and either 12 months of spontaneous amenorrhea or at least 6 months post-surgical bilateral oophorectomy and/or hysterectomy
- Age 45-75 years
- Body mass index (BMI) 18.5-32.0 kg/m2
- Clinical laboratory values that meet the following criteria prior to dosing on Day 1:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 x ULN
- Ability to adhere to the study visit schedule/procedures, and to understand and comply with protocol requirements
- Signed written informed consent
Exclusion
- Smokers (use of tobacco products within 3 months prior to screening)
- History of hepatitis B (HBsAg and HB core Ab), human immunodeficiency virus (HIV) antibody or active hepatitis C
- Positive drug or alcohol screen test at screening or on Day 1
- History of drug or alcohol abuse (as defined by the investigator) or required treatment for drug or alcohol use within 2 years of Day 1
- Donated or lost ≥ 500 mL of whole blood within 2 months prior to Day 1
- History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening; serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or any other drugs
- Systemic glucocorticoid therapy, statin medication, growth hormone, androgen, insulin, oral hormone replacement therapy or any other therapy (including investigational) with known or intended effects on muscle within 3 months prior to Day 1
- Anti platelet, anti-coagulant, or any other therapy (including investigational) with known or intended effects on bleeding risk within 1 week prior to Day 1 (Daily low-dose aspirin is allowed)
- Treatment with another investigational drug, device, or approved therapy for investigational use within 30 days prior to Day 1; administration of a biological product in the context of a clinical research study within 90 days prior to Day 1
- Participation in another clinical trial involving intervention with or without an investigational drug or device at any time during the study period
- Unwilling or unable to maintain physical activity at baseline level for the duration of the study
- For Cohorts 4-6 only, any condition that would prevent MRI scanning or compromise the ability to obtain a clear and interpretable scan of the thigh (e.g., pacemaker, knee/hip replacement, metallic implant, extreme claustrophobia, etc.)
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03478319
Start Date
February 15 2018
End Date
June 17 2019
Last Update
July 18 2019
Active Locations (1)
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1
Syneos Health
Québec, Canada, G1P0A2