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

Astrocyte Pharmaceuticals Inc.0 个研究点目标入组 44 人开始时间: 待定最近更新: 2024年4月9日

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•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.

•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.

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