Testing LH-001 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
This study is testing a new medication called LH-001 in healthy people to see if it's safe to take in single or multiple doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06546449 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of LH-001, administered as an oral single or multiple doses, in healthy participants. It is a first-in-human, randomized, double-blinded, placebo-controlled study consisting of two parts: single ascending doses (SAD) and multiple ascending doses (MAD). Participants will undergo a series of safety assessments and monitoring during their inpatient stays and follow-up visits to ensure their well-being throughout the study.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18-60 with a BMI between 18-29.9 kg/m2.
Not a fit: Patients with underlying health conditions or those taking prohibited medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data for LH-001, paving the way for its potential use in future treatments.
How similar studies have performed: Other studies involving first-in-human trials have shown success in establishing safety profiles for new compounds, making this approach a standard practice in clinical research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Emily E Shalosky
- Email: Emily.Shalosky@osumc.edu
- Phone: 6142935183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.