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A Study of ACE-2494 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03478319
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ACE-2494 or placebo Phase 1

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) will be enrolled and treated with study drug (ACE-2494 or placebo) on Day 1. Subjects will be randomized (3:1, ACE-2494: placebo) to receive one dose of either ACE-2494 or placebo, respectively, on Day 1.

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of ACE-2494 in healthy postmenopausal women. The secondary objectives are to characterize the pharmacokinetic (PK) profile and pharmacodynamic (PD) effects, including serum biomarkers, fat, lean, and bone mass (DXA), muscle volume and intramuscular fat fraction (MRI).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-2494 in Healthy Postmenopausal Women
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Cohort 1
ACE-2494 or placebo 0.06 mg/kg SC Day 1
Drug: ACE-2494 or placebo
Recombination fusion protein

Experimental: Cohort 2
ACE-2494 or placebo 0.2 mg/kg SC Day 1
Drug: ACE-2494 or placebo
Recombination fusion protein

Experimental: Cohort 3
ACE-2494 or placebo 0.6 mg/kg SC Day 1
Drug: ACE-2494 or placebo
Recombination fusion protein

Experimental: Cohort 4
ACE-2494 or placebo 1.0 mg/kg SC Day 1
Drug: ACE-2494 or placebo
Recombination fusion protein

Experimental: Cohort 5
ACE-2494 or placebo 2.0 mg/kg SC Day 1
Drug: ACE-2494 or placebo
Recombination fusion protein

Experimental: Cohort 6
ACE-2494 or placebo TBD (not to exceed 3.0 mg/kg SC) Day 1
Drug: ACE-2494 or placebo
Recombination fusion protein




Primary Outcome Measures :
  1. Number of participants with ACE-2494 treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: From initiation of treatment (Study Day 1) to end of follow-up period (Study Day 85) ]
    Adverse events (including both clinical observations and laboratory measurements), deemed related to ACE-2494 treat, will be recorded for each study subject


Secondary Outcome Measures :
  1. Determination of ACE-2494 serum Cmax [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Determination of maximum serum concentration of ACE-2494 following subcutaneous administration

  2. Determination of ACE-2494 serum Tmax [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Determination of time to maximum serum concentration of ACE-2494 following subcutaneous administration

  3. Determination of ACE-2494 serum T1/2 [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Determination of serum half-life of ACE-2494 following subcutaneous administration

  4. Determination of ACE-2494 AUC [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Determination of the area under the serum concentration curve of ACE-2494 following subcutaneous administration

  5. Quantitation of serum GDF8 following ACE-2494 treatment [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Quantitation of serum levels of growth differentiation factor (GDF)8 following treatment with ACE-2492

  6. Quantitation of serum BSAP following ACE-2494 treatment [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Quantitation of serum levels of bone-specific alkaline phosphatase (BSAP) following treatment with ACE-2494

  7. Quantitation of serum CTX following ACE-2494 treatment [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Quantitation of serum levels of carboxy-terminal collagen crosslinks (CTX) following treatment with ACE-2494

  8. Quantitation of serum FSH following ACE-2494 treatment [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Quantitation of serum levels of follicle stimulating hormone (FSH) following treatment with ACE-2494

  9. Determination of body composition following ACE-2494 treatment by DXA [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Regional and whole-body quantitation of fat mass by dual energy X-ray absorptiometry (DXA) following treatment with ACE-2494

  10. Determination of body composition following ACE-2494 treatment by DXA [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Regional and whole-body quantitation of lean mass by dual energy X-ray absorptiometry (DXA) following treatment with ACE-2494

  11. Determination of body composition following ACE-2494 treatment by DXA [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Regional and whole-body quantitation of bone mass by dual energy X-ray absorptiometry (DXA) following treatment with ACE-2494

  12. Determination of thigh muscle volume and intramuscular fat following ACE-2494 treatment by MRI for patients in Cohorts 4-6 only [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Determination of total muscle volume in the thigh by magnetic resonance imaging (MRI)

  13. Determination of thigh muscle volume and intramuscular fat following ACE-2494 treatment by MRI for patients in Cohorts 4-6 only [ Time Frame: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85) ]
    Determination of intramuscular fat in the thigh by magnetic resonance imaging (MRI)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Age 45-75 years
  3. Body mass index (BMI) 18.5-32.0 kg/m2
  4. Clinical laboratory values that meet the following criteria prior to dosing on Day 1:

    1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)
    2. Serum creatinine ≤ 1.5 x ULN
  5. Ability to adhere to the study visit schedule/procedures, and to understand and comply with protocol requirements
  6. Signed written informed consent

Exclusion Criteria:

  1. Smokers (use of tobacco products within 3 months prior to screening)
  2. History of hepatitis B (HBsAg and HB core Ab), human immunodeficiency virus (HIV) antibody or active hepatitis C
  3. Positive drug or alcohol screen test at screening or on Day 1
  4. 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
  5. Donated or lost ≥ 500 mL of whole blood within 2 months prior to Day 1
  6. 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
  7. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or any other drugs
  8. 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
  9. 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)
  10. 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
  11. Participation in another clinical trial involving intervention with or without an investigational drug or device at any time during the study period
  12. Unwilling or unable to maintain physical activity at baseline level for the duration of the study
  13. 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.)

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): NCT03478319


Contacts
Contact: Clinical Trial Manager (617) 576-2220 clinicaltrials249401@acceleronpharma.com

Locations
Canada
Syneos Health Recruiting
Québec, Canada, G1P0A2
Contact: Richard Larouche, MD       Richard.larouche@syneoshealth.com   
Sponsors and Collaborators
Acceleron Pharma, Inc.

Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03478319     History of Changes
Other Study ID Numbers: A2494-01
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acceleron Pharma, Inc.:
ACE-2494