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This is a Phase 2/3 multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of BHV-8000 in participants diagnosed with early PD who are untreated with any PD medications. This study also includes an optional 48-week Open-label (OL) Treatment Phase for those participants who are eligible to enter.

Who can Participate

Male and Female adults, 40-80 years of age, diagnosed with early Parkinson's disease. 1. Male or female participants 40-80 years of age, inclusive, at the time of informed consent. 2. Body mass index ≥18 kg/m2 at the Screening Visit. 3. The PI must inform candidates of the risk for potential immune suppression while receiving treatment with study drug. 4. If a live vaccine is to be administered, it must be completed at least 4 weeks before the baseline visit. 5. Participants must be able to swallow the pill whole without crushing. 6. Diagnosis of PD wtihin 2 years of the screening visit. 7. Have a score of ≤ 2.5 on the Modified Hoehn & Yahr Scale as assessed by the Investigator at the Screening Visit. 8. Have an MDS-UPDRS Part II score ≥ 3 at the Screening Visit. 9. Does not require treatment with any PD medications and the initiation of such treatment is not expected before the completion of the 48-week double blinded treatment phase. 10. SPECT consistent with a diagnosis of PD. 11. All FOCBP and non-sterile male participants must agree to use two forms of contraception. Exclusion criteria: 1. Medical history indicating a Parkinsonian syndrome other than idiopathic PD. 2. Treatment with PD medications. 3. Diagnosis of clinically significant central nervous system disease other than PD. 4. MoCA score ≤ 25 at the Screening Visit. 5. History or current evidence of major psychiatric illness. 6. Participants who indicate a yes response on the C-SSRS suicidal ideation quesstions 4 or 5. 7. Participants with history of schizophrenia or other chronic psychosis. 8. Cardiovascular health exclusions. 9. Infectious disease/immune status exclusions. 10. Oncologic health exclusions. 11. Contraception exclusions. 12. Gastrointestinal health exclusions: history of surgry known to interfere with absorption or excretion of drugs. History of acute or chronic medical conditions which could affect absorption of the study drug. History of diverticulitis or bowel perforation. 13. General health exclusions: current diagnosis or history of substance abuse or alcohol abuse. Significant trauma or major surgery or any clinically significant hospital admission. Planned surgery which requires general anesthesia that would take place durig nthe study. Any other current serious or unstable illnes of clinically significant hepatic, renal, pulmonary, gastrointestinal, neurological, autoimmune, immunological, infectious, hematological, malignant, or other conditions that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results. 14. Laboratory test exclusions. 15. Imaging test exclusions: have any contraindications for MRI, DaT-SPECT, or history of or screening brain MRI scan indicative of significant abnormality. 16. ECT testing exclusions: corrected QT interval > 450 msec in male participants and > 470 msec in female participants (QTc by method of Frederica), or a family history of long QT syndrome. Mobitz Type II second or third degree atrioventricular (AV) block or complete left bundle branch block, or complete right bundle branch block or intraventricular conduction defect with a QRS duration ≥ 130 msec (asymptomatic patients with first degree AV block may be included). Clinically significant abnormalities requiring treatment (e.g., acute or sub-acute myocardial infarction, serious tachy- or brady-arrhythmias) or that are indicative of serious underlying heart disease (e.g. , cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff-Parkinson-White syndrome and other clinically relevant abnormalities) which may affect participant safety or interpretation of study results.

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