NCT03478319

A Study of ACE-2494 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-2494 in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ACE-2494 or placebo	Recombination fusion protein

Timeline

• Start date: 2018-02-15
• Primary completion: 2019-06-13
• Completion: 2019-06-17
• First posted: 2018-03-27
• Last updated: 2019-07-18

Locations

1 site across 1 country: Canada