NL-OMON36923
Withdrawn
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- chronic low back pain
- Sponsor
- Abbott
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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