GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy, (PSP). In 75 patients diagnosed with PSPR Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) at five hospitals in Korea, subcutaneous administration of GV1001 0.56 or 1.12 mg/day will be conducted with multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective phase 2a.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GemVax & Kael

Criteria

Inclusion Criteria:

• Patients aged ≥41 years to ≤ 85 years.

• Clinical diagnosis of probable progressive supranuclear palsy (PSP).

• Patient is on a stable therapy for a neurological drug for at least 1 month prior to screening visit.

• Patients who are able to walk 3 meters or more independently or with assistive devices.

• Score 15 points ≥ on the Korean Mini-Mental Status Exam (K-MMSE) at the screening visit.

• Have reliable caregiver to accompany participant to all study visits.

• Patients and/or their representatives who have voluntarily provided a written consent for participation in this clinical study.

Exclusion Criteria:

• Patients who have Presence of structural lesions or Suspected concurrent onset of central nervous system diseases based on the CT/MRI scan results and neurological examinations performed within 12 months of screening or at screening.

• Patients with a history of known or suspected seizures.

• Patients with a recent unexplained loss of consciousness within 3 months prior to screening or a history of significant head trauma with loss of consciousness.

• Patients with acute or unstable cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes, or any other medical condition that can interfere with completing the clinical study.

• Patients with hypersensitivity reactions to the ingredients of the investigational product.

• Patients with a history of cancer within 5 years prior to screening.

• Patients with abnormal renal function.

• Patients with severe liver function abnormalities.

• Patients weighing ≤35 kg.

• Among the female subjects who does not agree to use proper contraception.

• Pregnant or breastfeeding women.

• Patients who participated in another clinical study within 4 weeks prior to screening and were administered investigational products or were applied investigational medical devices.

• Patients who were administered the study drug (GV1001) of this clinical study within 12 months prior to screening.

• Patients who participated in a clinical study for progressive supranuclear palsy within 6 months prior to screening.

• Other patients judged by the investigator as ineligible to participate in this clinical study.