LH-001 vs Placebo in Healthy Participants

Launched by CHIEN-LIANG LIN · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called LH-001 to see how safe it is and how well it can be tolerated when taken by healthy adults. The study will involve participants taking either LH-001 or a placebo (a sugar pill with no active medication) in different doses. The goal is to understand how the body reacts to LH-001, which may help in developing future treatments.

To participate, individuals must be healthy men or women aged 18 to 60 years, willing to stay overnight for monitoring, and meet certain health criteria, such as having a body mass index (BMI) between 18 and 26. Participants will need to follow specific guidelines about birth control if they are sexually active. The trial is not yet recruiting, so interested candidates will need to wait for further announcements. Those who qualify will be closely monitored, and their health will be assessed throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy males or females aged 18-60 years
• • 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 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 or presence of cancer
• • 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