A Partially Double-Blinded Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of AST-004 as a Short Loading Intravenous infusion Followed by AST-004 as a Continuous Infusion in Healthy Adult Subjects.

Completed

Conditions: cerebral infarction and traumatic brain injury
acute ischemic stroke

Registration Number: NL-OMON53360

Lead Sponsor: Astrocyte Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

1. Male or female subjects aged >= 18 to <= 65 years at the time of signing the
informed consent form (ICF).
2. Body mass index (BMI) >= 18.0 and <= 30.0 kg/m2.
3. Weight of 50.0 kg - 100.0 kg.
4. Women of childbearing potential who agree to use a highly effective method
of contraception for 3 months after the last dose of study drug or as per the
local regulation.

Exclusion Criteria

1. Presence of any contraindication to pharmacokinetic sampling, with
particular attention to lumbar punction in Part 2 (e.g., possible raised
intracranial pressure, thrombocytopenia or other bleeding diathesis, suspected
spinal epidural abscess)
2. History of seizures other than clearly documented febrile seizure prior to 2
years of age, myoclonus or other movement disorders, periodic paralysis,
unexplained loss of consciousness, structural neurological abnormalities,
traumatic brain injury including concussion within the last three years,
history of epilepsy, depression or suicidal ideation
3. Any clinically significant abnormality identified during pre-study (prior to
dosing) on full physical examination, vital signs, laboratory tests, and ECG
4. Any laboratory value noted here: Hgb Neutrophils <1.5 x 10 9/L, Platelets ULN, Total Bilirubin >ULN,
may be up to 1.5x ULN if Direct Bilirubin is repeated x1 during the screening period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy is not being assessed in this study. The primary endpoints are the<br /><br>safe and well tolerated administration of the study medication. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PK of AST-004 in plasma and CSF will be important in determining the dose of<br /><br>the study medication to be used in Phase 2 trials and to be used in any future<br /><br>Phase 1 studies. PK of AST-004 as well as identification of any major<br /><br>metabolites in urine and plasma will be obtained.<br /><br><br /><br>Mechanistic and pharmacodynamic biomarkers of AST-004 will also be assessed in<br /><br>the plasma and CSF including changes in cytokine levels.<br /><br></p><br>