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.

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. - CS0398-230004 Astrocyte

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53360

Enrollment

Registered

2023-02-21

Start date

2023-04-05

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

cerebral infarction and traumatic brain injury acute ischemic stroke

Interventions

AST-004 or matching placebo

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged >= 18 to = 18.0 and

Exclusion criteria

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 ULN, Total Bilirubin >ULN, may be up to 1.5x ULN if Direct Bilirubin is

Design outcomes

Primary

Measure	Time frame
Efficacy is not being assessed in this study. The primary endpoints are the safe and well tolerated administration of the study medication.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)