Study Evaluating Single Ascending Doses Of ILS-920

Wyeth is now a wholly owned subsidiary of Pfizer16 enrolled

Overview

This is a first-in-human study of ILS-920. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after administration of ascending single intravenous (IV) doses to healthy adult subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

ILS-920DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women of nonchildbearing potential * Aged 18 to 50 years inclusive at screening. Exclusion Criteria: * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * History of drug abuse within 1 year before study day 1.

Outcomes

Primary Outcomes

Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests.

Time frame: 48 hours after study drug administration

Secondary Outcomes

Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body.

Time frame: 48 hours after study drug administration

Data from ClinicalTrials.gov

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