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Link to original content: https://pubmed.ncbi.nlm.nih.gov/23169607
A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers - PubMed Skip to main page content
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Clinical Trial
. 2013 Mar;47(3):416-23.
doi: 10.1002/mus.23539. Epub 2012 Nov 21.

A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers

Kenneth M Attie  1 , Niels G Borgstein, Yijun Yang, Carolyn H Condon, Dawn M Wilson, Amelia E Pearsall, Ravi Kumar, Debbie A Willins, Jas S Seehra, Matthew L Sherman
Affiliations
Clinical Trial

A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers

Kenneth M Attie et al. Muscle Nerve. 2013 Mar.

Abstract

Introduction: 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.

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