RECRUITING

LH-001 vs Placebo in Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-06

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06546449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Emily E Shalosky

CONTACT

6142935183

Emily.Shalosky@osumc.edu

cassandra Heslin

CONTACT

Cassandra.Heslin@osumc.edu

Principal Investigator

Chien-Liang Glenn Lin, PhD

STUDY_DIRECTOR

Ohio State University

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43221

United States

Collaborators and Investigators

Sponsor: Chien-Liang Lin

Chien-Liang Glenn Lin, PhD, STUDY_DIRECTOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-06

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

LH-001

Additional Relevant MeSH Terms

Healthy