NL-OMON40320
Completed
Not Applicable
Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects with Painful Lumbar Radiculopathy - SC and IV doses SAD/MAD study BG00010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- low back pain
- Sponsor
- Biogen Idec
- Enrollment
- 78
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects
- •\-Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •\-Must be 18 to 75 years old at the time of informed consent.
- •\-Upper weight limits the number of SC injections per dose (maximum of 2 injections per dose.;Volunteers with Painful lumbar radiculopathy:
- •\-Subjects must have a diagnosis of painful lumbar radiculopathy, determined by the Investigator, including pain radiating down the leg following a dermatome, suggesting L4, L5, or S1 nerve root involvement. Painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit.
- •\-Subjects must rate their pain at 40 mm and more on the 100 mm VAS of the SF\-MPQ at the Screening and Baseline Visits.
- •\-All male and all female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
Exclusion Criteria
- •All Subjects:
- •\-History of or positive screening test for hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg] and/or positive for hepatitis B core antibody \[HBcAb] at Screening), or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb immunoglobulin G (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
- •\-History of malignancy or clinically relevant (as determined by the Investigator) allergies; cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to painful lumbar radiculopathy), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- •\-Relevant history of illicit drug or alcohol abuse (as defined by the Investigator) within 1 year prior to the Screening Visit. Subjects must be willing to restrain from the use of illicit drug or consumption of alcoholic beverages within 24 hours prior to dosing on Day 1, and during the inpatient period.
- •\-History of severe allergic or anaphylactic drug\-related reactions.
- •\-History of skin or systemic condition that predisposes to have pruritus, as determined by the Investigator.
- •\-Clinically relevant abnormal electrocardiogram (12\-lead ECG) at the Screening or Baseline Visits, as determined by the Investigator, or a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval \>450 msec for females or \>430 msec for males) at the Screening or Baseline Visits.
- •\-Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
- •\-Fever (body temperature \>38°C) or symptomatic viral or bacterial infection within 2 weeks prior to the Baseline Visit.
- •\-Any live or attenuated immunization/vaccination within 28 days prior to the Baseline Visit.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance after Multiple Oral Dosing of LY2623091 in Healthy Volunteerschronic kidney diseaseKidney failure10038430NL-OMON36630Eli Lilly32
Completed
Not Applicable
Study of the Safety, Tolerability and Pharmacokinetics of LY2623091 after Single Oral Dosing in Healthy SubjectsNL-OMON34283Chorus LRL (Division of Eli Lilly)18
Completed
Not Applicable
A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy ParticipantsNL-OMON50998Eli Lilly16
Active, not recruiting
Phase 1
Safety, Tolerability and Pharmacokinetics of Tirzepatide in Pediatric Participants with Obesity.Weight managementMedDRA version: 20.0Level: HLTClassification code 10027428Term: Metabolic disorders NECSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]EUCTR2024-000081-22-Outside-EU/EEAEli Lilly and Company
Completed
Not Applicable
Study of the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral dosing in healthy subjects including brain Serotonin Transporter (SERT) occupancy by Positron Emission Tomography (PET).chronische pijn aan beschadigde organen.visceral painNL-OMON34068Eli Lilly51