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Locally acting ACE-083 increases muscle volume in healthy volunteers
- Source :
- Muscle & Nerve. 57:921-926
- Publication Year :
- 2018
- Publisher :
- Wiley, 2018.
-
Abstract
- Introduction ACE-083 is a locally acting follistatin-based therapeutic that binds myostatin and other muscle regulators and has been shown to increase muscle mass and force in neuromuscular disease mouse models. This first-in-human study examined these effects. Methods In this phase 1, randomized, double-blind, placebo-controlled, dose-ranging study in healthy postmenopausal women, ACE-083 (50-200 mg) or placebo was administered unilaterally into rectus femoris (RF) or tibialis anterior (TA) muscles as 1 or 2 doses 3 weeks apart. Results Fifty-eight postmenopausal women were enrolled, 42 ACE-083 and 16 placebo. No serious adverse events (AE), dose-limiting toxicities, or discontinuations resulting from AEs occurred. Maximum (mean ± SD) increases in RF and TA muscle volume were 14.5% ± 4.5% and 8.9% ± 4.7%, respectively. No significant changes in mean muscle strength were observed. Discussion ACE-083 was well tolerated and resulted in significant targeted muscle growth. ACE-083 may have the potential to increase muscle mass in a wide range of neuromuscular disorders. Muscle Nerve 57: 921-926, 2018.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Neuromuscular disease
Physiology
Myostatin
Muscle volume
Placebo
Muscle hypertrophy
03 medical and health sciences
Cellular and Molecular Neuroscience
0302 clinical medicine
Physiology (medical)
Internal medicine
medicine
Muscular dystrophy
Adverse effect
biology
business.industry
medicine.disease
030104 developmental biology
Endocrinology
biology.protein
Neurology (clinical)
business
030217 neurology & neurosurgery
Follistatin
Subjects
Details
- ISSN :
- 0148639X
- Volume :
- 57
- Database :
- OpenAIRE
- Journal :
- Muscle & Nerve
- Accession number :
- edsair.doi...........89f461a8e53dea3d012117c4b8416994