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

Muscle and Nerve

Volumn 47, Issue 3, 2013, Pages 416-423

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

^a Acceleron Pharma Inc   (United States)

Author keywords

ACE 031; Activin; Myostatin; Neuromuscular disease; Placebo controlled clinical trial

Indexed keywords

ALKALINE PHOSPHATASE; BISPHOSPHONIC ACID DERIVATIVE; FOLLITROPIN; LEPTIN; MYOSTATIN; PLACEBO; RAMATERCEPT;

AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONTACT DERMATITIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; GRIP STRENGTH; HEADACHE; HEMATOMA; HUMAN; IMMUNOASSAY; INJECTION SITE ERYTHEMA; LIPID METABOLISM; MAXIMUM PLASMA CONCENTRATION; MUSCLE GROWTH; MUSCLE MASS; NUCLEAR MAGNETIC RESONANCE IMAGING; OROPHARYNX PAIN; ORTHOSTATIC HYPOTENSION; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETICULOCYTE COUNT; SIDE EFFECT; THROMBOCYTE COUNT; THYROID FUNCTION; THYROTROPIN BLOOD LEVEL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ABSORPTIOMETRY, PHOTON; ACTIVIN RECEPTORS, TYPE II; ADIPOSE TISSUE; AGED; BIOLOGICAL MARKERS; BODY COMPOSITION; BONE DENSITY; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FEMALE; FOLLICLE STIMULATING HORMONE; HUMANS; MAGNETIC RESONANCE IMAGING; MIDDLE AGED; PHARMACEUTICAL SOLUTIONS;

EID: 84874240024     PISSN: 0148639X     EISSN: 10974598     Source Type: Journal    
DOI: 10.1002/mus.23539     Document Type: Article

References (23)

1. Souza TA, Chen X, Guo Y, Sava P, Zhang J, Hill JJ, et al. Proteomic identification and functional validation of activins and bone morphogenetic protein 11 as candidate novel muscle mass regulators. Mol Endocrinol 2008;22:2689-2702.
2. Tsuchida K, Nakatani M, Uezumi A, Murakami T, Cui X. Signal transduction pathway through activin receptors as a therapeutic target of musculoskeletal diseases and cancer. Endocr J 2008;55:11-21.
3. Lee SJ, McPherron AC. Regulation of myostatin activity and muscle growth. Proc Natl Acad Sci U S A 2001;98:9306-9311.
4. Lee SJ, Reed LA, Davies MV, Girgenrath S, Goad ME, Tomkinson KN, et al. Regulation of muscle growth by multiple ligands signaling through activin type II receptors. Proc Natl Acad Sci U S A 2005;102:18117-18122.
5. McPherron AC, Lee SJ. Double muscling in cattle due to mutations in the myostatin gene. Proc Natl Acad Sci U S A 1997;94:12457-12461.
6. McPherron AC, Lawler AM, Lee SJ. Regulation of skeletal muscle mass in mice by a new TGF-beta superfamily member. Nature 1997;387:83-90.
7. Mosher DS, Quignon P, Bustamante CD, et al. A mutation in the myostatin gene increases muscle mass and enhances racing performance in heterozygote dogs. PLoS Genet 2007;3:e79.
8. Schuelke M, Wagner KR, Stolz LE, Hubner C, Riebel T, Komen W, et al. Myostatin mutation associated with gross muscle hypertrophy in a child. N Engl J Med 2004;350:2682-2688.
9. Lee SJ. Regulation of muscle mass by myostatin. Annu Rev Cell Dev Biol 2004;20:61-86.
10. Sako D, Grinberg AV, Liu J, Davies MV, Castonguay R, Maniatis S, et al. Characterization of the ligand binding functionality of the extracellular domain of activin receptor type IIb. J Biol Chem 2010;285:21037-21048.
11. Koncarevic A, Cornwall-Brady M, Pullen A, Davies M, Sako D, Liu J, et al. A soluble activin receptor type IIb prevents the effects of androgen deprivation on body composition and bone health. Endocrinology 2010;151:4289-4300.
12. Cadena SM, Tomkinson KN, Monnell TE, Spaits MS, Kumar R, Underwood KW, et al. Administration of a soluble activin type IIB receptor promotes skeletal muscle growth independent of fiber type. J Appl Physiol 2010;109:635-642.
13. Akpan I, Goncalves MD, Dhir R, Yin X, Pistilli EE, Bogdanovich S, et al. The effects of a soluble activin type IIB receptor on obesity and insulin sensitivity. Int J Obes (Lond) 2009;33:1265-1273.
14. Pistilli EE, Bogdanovich S, Mosqueira M, Lachey J, Seehra J, Khurana TS. Pretreatment with a soluble activin type IIB receptor/Fc fusion protein improves hypoxia-induced muscle dysfunction. Am J Physiol Regul Integr Comp Physiol 2010;298:R96-R103.
15. Pistilli EE, Bogdanovich S, Goncalves MD, Ahima RS, Lachey J, Seehra J, Khurana T. Targeting the activin type IIB receptor to improve muscle mass and function in the mdx mouse model of Duchenne muscular dystrophy. Am J Pathol 2011;178:1287-1297.
16. Morrison BM, Lachey JL, Warsing LC, Ting BL, Pullen AE, Underwood KW, et al. A soluble activin type IIB receptor improves function in a mouse model of amyotrophic lateral sclerosis. Exp Neurol 2009;217:258-268.
17. Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, et al. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med 2003;349:1207-1215.
18. Boonen S, Marin F, Mellstrom D, Xie L, Desaiah D, Krege JH, et al. Safety and efficacy of teriparatide in elderly women with established osteoporosis: bone anabolic therapy from a geriatric perspective. J Am Geriatr Soc 2006;54:782-789.
19. Wagner KR, Fleckenstein JL, Amato AA, Barohn RJ, Bushby K, Escolar DM, et al. A phase I/II trial of MYO-029 in adult subjects with muscular dystrophy. Ann Neurol 2008;63:561-571.
20. Zhou X, Wang JL, Lu J, Song Y, Kwak KS, Jiao Q, et al. Reversal of cancer cachexia and muscle wasting by ActRIIB antagonism leads to prolonged survival. Cell 2010;142:531-543.
21. Bogdanovich S, Krag TO, Barton ER, Morris LD, Whittemore LA, Ahima RS, et al. Functional improvement of dystrophic muscle by myostatin blockade. Nature 2002;420:418-421.
22. Bogdanovich S, Perkins KJ, Krag TO, Whittemore LA, Khurana TS. Myostatin propeptide-mediated amelioration of dystrophic pathophysiology. FASEB J 2005;19:543-549.
23. Struthers RS, Nicholls AJ, Grundy J, Chen T, Jimenez R, Yen SS, et al. Suppression of gonadotropins and estradiol in premenopausal women by oral administration of the nonpeptide gonadotropin-releasing hormone antagonist elagolix. J Clin Endocrinol Metab 2009;94:545-551.