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Recruiting NCT06546449

LH-001 vs Placebo in Healthy Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LH-001, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

This is a first-in-human, randomized, double-blinded, placebo-controlled study. This study consists of two parts: (1) single ascending doses in 4 cohorts (SAD) and (2) 14-day multiple ascending doses in 3 cohorts (MAD). Cohorts may be added or removed if needed due to safety considerations or deviations of actual PK parameters from predicted values.

The SAD study consists of a screening visit, a 2-day inpatient stay (Day 1-2), a return visit for safety assessments on Day 3, Day 4, and Day 8.

The MAD study consists of a screening visit, a 2-day inpatient stay (Day 1-2), daily return for dosing and safety assessments (Day 3-13), a 2-day inpatient stay (Day 14-15), and a follow-up by phone (Day 21).

Interventions

  • Drug LH-001
    LH-001 will be administered oral
  • Drug Placebo
    Placebo will be administered oral

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Maximum concentration (Cmax) [Time frame: Day 1 for all cohorts and Day 14 for MAD cohorts]
  • Time to reach maximum concentration (Tmax) [Time frame: Day 1 for all cohorts and Day 14 for MAD cohorts]
  • Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUC0-last) [Time frame: Day 1 for all cohorts and Day 14 for MAD cohorts]
  • Time for LH-001 concentration to fall to half of its original value (T½) [Time frame: Day 1 for all cohorts and Day 14 for MAD cohorts]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Ohio State University — Columbus

Identifiers

NCT: NCT06546449 · 2024W0061 · 1U01AG068822-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗