Phase 1 Study of ART5803 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 investigational medical device within 30 days prior to Screening, or is required to use any investigational agent prior to completion of all scheduled study assessments.
• ✕. Has a condition of such severity and acuity, in the opinion of the Investigator, that it warrants immediate surgical intervention or other treatment or may not allow safe participation in the study.
• ✕. The participant has a history of cancer, apart from squamous cell carcinoma of the skin or basal cell carcinoma of the skin. Squamous cell and basal cell carcinomas should be treated with documented success of curative therapy \>3 months prior to randomization.
• ✕. The participant has any clinically 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. It is the responsibility of the Investigator to assess the clinical significance; 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 that has had 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 that 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 from 2 weeks before the first study drug administration until the end of the inpatient stay (Part 1: Day 5; Part 2: Day 29).
• ✕. 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 exam, non-communicating hydrocephalus or intracranial mass, or prior history of spinal mass or trauma.