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) - 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)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007062

Enrollment

Registered

2012-01-16

Start date

2012-01-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis (ALS)

Interventions

Single intrathecal infusion of KP-100IT at the low dose Single intrathecal infusion of KP-100IT at the middle dose Single intrathecal infusion of KP-100IT at the high dose Multiple intrathecal infusio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 'Clinically Definite ALS', 'Clinically Probable ALS' or 'Clinically Possible-Laboratory-supported ALS' by El Escorial Criteria - Within 3 years after onset of the disease - Stage I or II in ALS severity classification

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of KP-100IT Safety of SM-1500	—

Countries

Japan

Contacts

Public ContactTetsushi Abe

Kringle Pharma, Inc. Department of Pharmaceutical Development

info@kringle-pharma.com072-641-8739

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026