NL-OMON36923撤回不适用
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injection of ABT-110 in Healthy Volunteers and Subjects with Chronic Low Back Pain - ABT-110 M12-143
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Abbott
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy Volunteers: Male or female aged 18-55 years; females must be postmenopausal or surgically sterilized; BMI between 18 and 29 inclusive; general good health.
- •CLBP Subjects: Male or female aged 18-60 years; females must be postmenopausal or surgically sterilized; chronic pain located below 12th rib and above lower gluteal fold of at least 6 months duration and meeting protocol-specified pain severity criteria; must be currently taking an NSAID, atypical analgesic (e.g. tramadol or tapentadol), or opioid analgesic for CLBP with inadequate analgesia.
排除标准
- •Healthy Volunteers: Any clinically significant medical problems.
- •CLBP Subjects: Any radiation of pain below the lower gluteal fold; any back injury within 3 months prior to study drug; history of back surgery within 1 year prior to study drug; radiographic evidence (x-ray) of osteoarthritis (OA) in any shoulder, hip or knee joint; history of osteonecrosis (avascular necrosis) or rapidly progressive OA in any joint; use of corticosteroids within the past year that meets protocol-specified criteria.
研究者
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