Study Evaluating Single Ascending Doses Of ILS-920

Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ILS-920 Administered Intravenously To Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00827190

Enrollment

Registered

2009-01-22

Start date

2009-02-28

Completion date

2009-07-31

Last updated

2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke

Brief summary

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.

Interventions

DRUGILS-920

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests.	48 hours after study drug administration

Secondary

Measure	Time frame
Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body.	48 hours after study drug administration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026