A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Phase 1
- Conditions
- Amyotrophic lateral sclerosis (ALS)
- Registration Number
- JPRN-UMIN000007062
- Lead Sponsor
- Kringle Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
-Have a serious disorder in any systems or have a serious metabolic defect, so that the investigators decide to be unsuitable for participation in the trial. -Have hemoglobin A1c 6.1 (JDS value) or more. -Any observation of diseases/symptomes below; malignant neoplasm, intrathecal infection/mass, proliferative retinopathy, %VC less than 70% in spirogram -Have a history of intolerance to transplantation of medical devices -Have received an investigational drugs or devices within a month before onformed consent -Be unsuitable for participation in the trial for any reason, according to the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of KP-100IT Safety of SM-1500
- Secondary Outcome Measures
Name Time Method