JPRN-UMIN000007062
Completed
Phase 1
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) - 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)
ConditionsAmyotrophic lateral sclerosis (ALS)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Amyotrophic lateral sclerosis (ALS)
- Sponsor
- Kringle Pharma, Inc.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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