LH-001 vs Placebo in Healthy Participants

Exclusion Criteria

• •Taking any prescription medications outlined in the prohibited/conditional drug list (see Section 6.8.1)
• •History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• •History or presence of major disorder of any other major organ system (cardiovascular, respiratory, central nervous system, or endocrine system)
• •History of cancer within 5 years of consent (exceptions are squamous and basal cell carcinomas of the skin)
• •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing.
• •History or presence of alcohol or substance abuse
• •History of chronic or current use of recreational or illicit drugs
• •History of, or treatment for, major psychiatric illness
• •History of, or treatment for, seizures or epilepsy
• •Pregnant or breast-feeding females
• •History of, or treatment for, an autoimmune disease (e.g., Rheumatoid Arthritis, Multiple Sclerosis, Myasthenia Gravis, etc.)
• •History of asplenia, hyposplenia, or splenectomy
• •History or presence of drug hypersensitivity
• •Poor venous access
• •Receipt of investigational therapy within 4 months prior to screening
• •Current or previous use of systemic corticosteroids or other systemic immunosuppressive agents 4 weeks prior to dosing
• •Current or previous use of NMDA antagonists 4 weeks prior to dosing
• •Clinically significant findings in the opinion of the investigator in the laboratory, physical examination, or vital sign assessments
• •Evidence of active Hepatitis B, Hepatitis C, or HIV on laboratory testing
• •Any clinically significant ECG abnormality in the opinion of the investigator
• •Plasma or blood donation within the last 4 weeks
• •Positive drug or alcohol screen
• •Any contraindication to or unable to tolerate a LP, for those who consented to the procedure, including the use of anti-coagulant medications. Daily administration of 81 mg aspirin will be allowed
• •Any concurrent condition that, in the opinion of the investigator, would interfere with the evaluation of LH-001
• •Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this CSSRS Item 5 occurred within the last 6 months OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred in the last 2 years