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 Pai

Withdrawn

Conditions: chronic low back pain
10028302

Registration Number: NL-OMON36923

Lead Sponsor: Abbott

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics, safety and tolerability in healthy volunteers</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Relative bioavailability of subcutaneously versus intravenously<br /><br>administration of the study drug<br /><br>- Pharmacokinetics, safety and tolerability in subjects with CLBP</p><br>