NCT06679322

The Androtriol Injection for the Treatment of Acute Ischemic Stroke

A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, phase IIb clinical trial of Androtriol injection for the treatment of acute ischemic stroke. The goal of this trial is to explore the efficacy and safety of different doses of Androtriol injection in patients with acute ischemic stroke (AIS) who received vascular recanalization treatment within 24 hours of symptom onset. Participants will receive a low-dose Androtriol injection (100 mg BID), a high-dose Androtriol injection (300 mg BID), or a placebo intravenously within 24 hours of stroke onset. They will be treated twice daily (every 12 hours) for 7 days, with a total of 14 doses over the course of the study. Each infusion will last approximately 30±5 minutes.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Androtriol Injection (High-dose group)	Participants will receive 30 mL of Androtriol Injection per dose, administered every 12 hours for 7 consecutive days. Each infusion will be administered over a period of 30±5 minutes.
DRUG	Androtriol Injection (Low-dose group)	Participants will receive 10 mL of Androtriol Injection combined with 20 mL of placebo (Hydroxypropyl Beta-Cyclodextrin Injection) per dose, administered every 12 hours for 7 consecutive days. Each infusion will be administered over a period of 30±5 minutes.
DRUG	Hydroxypropyl-β-cyclodextrin injection	Participants will receive 30 mL of Hydroxypropyl-β-cyclodextrin injection per dose, administered every 12 hours for 7 consecutive days. Each infusion will be completed within 30±5 minutes.

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-09-30
• Completion: 2025-10-30
• First posted: 2024-11-07
• Last updated: 2024-11-07