title: A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers.
abstract: BACKGROUND
  ACE-031 is a soluble form of activin receptor type IIB (ActRIIB). ACE-031 promotes muscle growth by binding to myostatin and other negative regulators of muscle mass.
  
  
  METHODS
  This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  
  
  RESULTS
  ACE-031 was generally well-tolerated. Adverse events included injection site erythema. Mean ACE-031 AUC(0-∞) and C(max) increased linearly with dose; mean T(½) was 10-15 days. Statistically significant increases in mean total body lean mass (3.3%; P = 0.03, by DXA) and thigh muscle volume (5.1%; P = 0.03, by MRI) were observed at day 29 in the 3 mg/kg group. Statistically significant changes in serum biomarkers suggest ACE-031 also improved bone and fat metabolism.
  
  
  CONCLUSIONS
  Single-dose ACE-031 treatment was generally well-tolerated and resulted in increases in muscle mass in healthy postmenopausal women.
authors.affiliation: Department of Medical Research, Acceleron Pharma, Inc., 128 Sidney Street, Cambridge, Massachusetts 02139, USA.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Attie
authors.forename: Niels G
authors.initials: NG
authors.lastname: Borgstein
authors.forename: Yijun
authors.initials: Y
authors.lastname: Yang
authors.forename: Carolyn H
authors.initials: CH
authors.lastname: Condon
authors.forename: Dawn M
authors.initials: DM
authors.lastname: Wilson
authors.forename: Amelia E
authors.initials: AE
authors.lastname: Pearsall
authors.forename: Ravi
authors.initials: R
authors.lastname: Kumar
authors.forename: Debbie A
authors.initials: DA
authors.lastname: Willins
authors.forename: Jas S
authors.initials: JS
authors.lastname: Seehra
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Sherman
mesh_terms: D015502:Absorptiometry, Photon; D030301:Activin Receptors, Type II / Q000008:administration & dosage / Q000494:pharmacology*; D000273:Adipose Tissue / Q000187:drug effects; D000368:Aged; D015415:Biomarkers; D001823:Body Composition / Q000187:drug effects; D015519:Bone Density; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D019999:Pharmaceutical Solutions
chemical_list: D015415:Biomarkers; D019999:Pharmaceutical Solutions; D005640:Follicle Stimulating Hormone; C579679:ACVR2B protein, human; D030301:Activin Receptors, Type II