Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants

Exclusion criteria

• ✕. The participant is pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
• ✕. The participant has used an investigational product or medical device within 30 days of Screening or for significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may interfere with the evaluation or administration of the study drug, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk including any significant acute or chronic medical condition. The Investigator is responsible for assessing the clinical significance of findings from health assessments and evaluations; however, consultation with the medical monitor may be warranted.
• ✕. Has a concurrent disease or condition that, in the view of the Principal Investigator, places the participant at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or would affect safety. Participants with fully resolved childhood asthma with no reoccurrences or hospitalizations remain eligible for participation.
• ✕. The participant is a regular smoker (cigarettes, e-cigarettes, and vaping included), defined as smoking daily. Participants who are non-daily smokers (up to ≤5 cigarettes per week \[or vaping or e-cigarette equivalent\]) are permitted to participate in the study and must agree to refrain from smoking during the in-patient stays.
• ✕. The participant has a contraindication to undergo LP, including international normalized ratio (INR) \>1.4 or other coagulopathy, platelet cell count of \<120,000/µL, infection at the desired LP site, current use of anti-coagulant medication except for low dose acetylsalicylic acid, degenerative arthritis, spinal scoliosis, back surgery, suspected increased intracranial pressure on history or neurologic examination, non-communicating hydrocephalus or intracranial mass, or prior history of spinal mass or trauma.
• ✕. The participant has a severe drug allergic history or anaphylaxis to 2 or more food products or medicines (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or lidocaine).
• ✕. The participant has a known history of allergy or reaction to any component of the investigational agent formulation or IVIG or any of its components, or a history of anaphylaxis or severe systemic reaction to blood products or following any biologic therapy.
• ✕. The participant has a history of alcohol abuse or drug addiction in the past 12 months.