NCT03478319已完成1 期

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

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2018年2月15日最近更新: 2019年7月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 48
试验地点: 1
主要终点: Number of participants with ACE-2494 treatment-related adverse events as assessed by CTCAE v5.0

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 45 Years 至 75 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Postmenopausal women, with menopause defined by follicle stimulating hormone (FSH) level > 40 IU/L and either 12 months of spontaneous amenorrhea or at least 6 months post-surgical bilateral oophorectomy and/or hysterectomy
•Age 45-75 years
•Body mass index (BMI) 18.5-32.0 kg/m2
•Clinical laboratory values that meet the following criteria prior to dosing on Day 1:
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)
•Serum creatinine ≤ 1.5 x ULN
•Ability to adhere to the study visit schedule/procedures, and to understand and comply with protocol requirements
•Signed written informed consent

排除标准

•Smokers (use of tobacco products within 3 months prior to screening)
•History of hepatitis B (HBsAg and HB core Ab), human immunodeficiency virus (HIV) antibody or active hepatitis C
•Positive drug or alcohol screen test at screening or on Day 1
•History of drug or alcohol abuse (as defined by the investigator) or required treatment for drug or alcohol use within 2 years of Day 1
•Donated or lost ≥ 500 mL of whole blood within 2 months prior to Day 1
•History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening; serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
•History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or any other drugs
•Systemic glucocorticoid therapy, statin medication, growth hormone, androgen, insulin, oral hormone replacement therapy or any other therapy (including investigational) with known or intended effects on muscle within 3 months prior to Day 1
•Anti platelet, anti-coagulant, or any other therapy (including investigational) with known or intended effects on bleeding risk within 1 week prior to Day 1 (Daily low-dose aspirin is allowed)
•Treatment with another investigational drug, device, or approved therapy for investigational use within 30 days prior to Day 1; administration of a biological product in the context of a clinical research study within 90 days prior to Day 1
•Participation in another clinical trial involving intervention with or without an investigational drug or device at any time during the study period
•Unwilling or unable to maintain physical activity at baseline level for the duration of the study
•For Cohorts 4-6 only, any condition that would prevent MRI scanning or compromise the ability to obtain a clear and interpretable scan of the thigh (e.g., pacemaker, knee/hip replacement, metallic implant, extreme claustrophobia, etc.)