LH-001 vs Placebo in Healthy Participants

Inclusion Criteria:

• Healthy males or females aged 18-60 years at the time of consent

• Must provide written informed consent

• Physically and mentally able and willing to participate in the safety and otherassessments including staying overnight

• BMI 18-29.9 kg/m2

• Sexually active male participants, sexually active female participants ofchildbearing potential, and their sexual partners are to adhere to the contraceptionrequirements. These requirements include utilizing highly effective birth control (including hormonal methods, intrauterine devices, and/or barrier methods) from thescreening phase through the completion of the last study follow-up. Note, thebarrier method may not be used as a standalone method and must be combined with anadditional approved method.

• Participants taking non-prescribed medication must cease taking the medication forat least 48 hours prior to dosing of LH-001.

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 othercondition known to interfere with absorption, distribution, metabolism, or excretionof 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 cellcarcinomas of the skin)

• Any clinically important illness, medical/surgical procedure, or trauma within 4weeks 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 systemicimmunosuppressive 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 thelaboratory, 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 theprocedure, 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 interferewith the evaluation of LH-001

• Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (ActiveSuicidal Ideation with Some Intent to Act, Without Specific Plan) and whose mostrecent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (ActiveSuicidal Ideation with Specific Plan and Intent) and whose most recent episodemeeting criteria for this CSSRS Item 5 occurred within the last 6 months OR Subjectswho answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt,interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose mostrecent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Itemsoccurred in the last 2 years