RecruitingPhase 1NCT06546449

LH-001 vs Placebo in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Escalating Doses of LH-001 in Healthy Participants

Sponsor

Chien-Liang Lin

Enrollment

56 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of LH-001 when administered as an oral, single or multiple dose(s) at ascending dose levels in healthy participants.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

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 other assessments including staying overnight
BMI 18-29.9 kg/m2
Sexually active male participants, sexually active female participants of childbearing potential, and their sexual partners are to adhere to the contraception requirements. These requirements include utilizing highly effective birth control (including hormonal methods, intrauterine devices, and/or barrier methods) from the screening phase through the completion of the last study follow-up. Note, the barrier method may not be used as a standalone method and must be combined with an additional approved method.
Participants taking non-prescribed medication must cease taking the medication for at least 48 hours prior to dosing of LH-001.

Exclusion Criteria25

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