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Cerebral Stroke clinical trials

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NCT ID: NCT06087094 Not yet recruiting - Cerebral Stroke Clinical Trials

A Trial of HRS-7450 in Chinese Healthy Volunteers

Start date: October 2023
Phase: Phase 1
Study type: Interventional

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending doses of HRS-7450 given to healthy subjects, compared to placebo..

NCT ID: NCT05691244 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

Start date: November 2024
Phase: Phase 3
Study type: Interventional

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.