A Study of ACE-2494 in Healthy Subjects

Status Completed

Clinical Trial Summary

The purpose of the study is to assess safety, tolerance, pharmacokinetic, and pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT03478319
Study type	Interventional
Source	Acceleron Pharma, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	February 15, 2018
Completion date	June 17, 2019

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