Recruiting
Phase 1

LH-001

Sponsor:

Chien-Liang Lin

Code:

NCT06546449

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

LH-001

Placebo

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT06546449

Start date

May 5, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 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 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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAD Cohort 1

Participants will be administered a single 12.5 mg dose of LH-001

experimental: SAD Cohort 2

Participants will be administered a single 25 mg dose of LH-001

experimental: SAD Cohort 3

Participants will be administered a single 50 mg dose of LH-001

experimental: SAD Cohort 4

Participants will be administered a single 100 mg dose of LH-001

experimental: MAD Cohort 1

Participants will be administered multiple 25 mg doses of LH-001

experimental: MAD Cohort 2

Participants will be administered multiple 50 mg doses of LH-001

experimental: MAD Cohort 3

Participants will be administered multiple 100 mg doses of LH-001

placebo comparator: SAD Placebo cohorts 1, 2, 3 and 4

Participants will be administered a single dose of placebo

placebo comparator: MAD Placebo cohorts 1, 2 and 3

Participants will be administered multiple doses of placebo

Interventions

LH-001

LH-001 will be administered oral

Placebo

Placebo will be administered oral

Primary outcome measure

  • Percentage of participants who experience at least one treatment-emergent AE [ Time Frame: 8 days for SAD and 21 days for MAD ]
  • Percentage of participants who discontinue due to an AE [ Time Frame: 8 days for SAD and 21 days for MAD ]
  • Percentage of participants who meet the markedly abnormal criteria for vital sign measurements at least once post-dose [ Time Frame: 8 days for SAD and 21 days for MAD ]
  • Percentage of participants who meet the markedly abnormal criteria for safety ECG parameters at least once post-dose [ Time Frame: 8 days for SAD and 21 days for MAD ]
  • Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose [ Time Frame: 8 days for SAD and 21 days for MAD ]

Central Contacts and Locations

Central contacts

Sydney E Harmon

614-685-8660Sydney.Harmon@osumc.edu

cassandra Heslin

Cassandra.Heslin@osumc.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Sydney Harmon

614-685-8660Sydney.Harmon@osumc.edu

Cassandra Heslin

Cassandra.Heslin@osumc.edu

Principal Investigator:

Douglas Scharre, MD

More Information

Sponsor

Chien-Liang Lin

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • LH-001

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chien-Liang Lin on 2026-06-17.