NCT02586233

Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).

Conditions

• Acute Ischemic Stroke
• Thrombotic Disease

Interventions

Type	Name	Description
DRUG	DS-1040b	DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period
DRUG	Placebo	0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-08-13
• Completion: 2019-08-13
• First posted: 2015-10-26
• Last updated: 2020-09-09
• Results posted: 2020-09-09

Locations

55 sites across 11 countries: United States, Australia, Czechia, France, Germany, Italy, Slovakia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study