NCT05585606

Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Silver Creek Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

Detailed description

This is a Phase 2 randomized, placebo-controlled, double-blind study that will be conducted in 2 parts: sequential dose escalation in Part A, followed by dose expansion in Part B. In Part A, approximately 60 evaluable subjects will be assigned 1:1:1:3 overall to Cohort 1, Cohort 2, Cohort 3, or placebo. Doses of scp776 will be tested sequentially in 3 cohorts, each in parallel with a volume-matched placebo randomized as 1:1 scp776:placebo within each cohort, to maintain the overall 1:1:1:3 ratio. Subjects will receive doses of either normal saline (placebo) or scp776, approximately 24 hours apart.• Cohort 1 dose regimen:- 1.9 mg/kg• Cohort 2 dose regimen:- 3.8 mg/kg• Cohort 3 dose regimen:- 4.8 mg/kg Upon completion of Part A, the study will proceed into Part B (dose expansion), in which approximately 40 subjects will be randomized 3:1 to the chosen scp776 therapeutic dose from Part A or volume-matched placebo.

Conditions

• Acute Ischemic Stroke (AIS)

Interventions

Type	Name	Description
DRUG	Placebo	Volume Matched Placebo
DRUG	scp776 (1.9 mg/kg)	Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes \- 1.9 mg/kg
DRUG	scp776 (3.8 mg/kg)	Cohort 2 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes \- 3.8 mg/kg
DRUG	scp776 (4.8 mg/kg)	Cohort 3 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 4.8 mg/kg
DRUG	scp776 (all dose levels)	A composite group encompassing all participants who received any dose level of the investigational drug under evaluation.

Timeline

• Start date: 2022-10-19
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2022-10-19
• Last updated: 2026-02-24

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study