LH-001 for Healthy Volunteers

Overseen By Douglas Scharre, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Chien-Liang Lin

Must not be taking: Corticosteroids, NMDA antagonists

Disqualifiers: Cancer, Substance abuse, Psychiatric illness, Autoimmune disease, others

Compensation: Varies

Number of Visits: 4

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new treatment called LH-001, an experimental treatment, to determine its safety and tolerability in healthy individuals. Participants are divided into groups to receive varying amounts of LH-001, either as a single dose or multiple doses, while others receive a placebo, a substance with no active drug. The trial seeks healthy individuals who are physically and mentally able, willing to stay overnight for assessments, and not currently taking certain medications or using drugs. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any non-prescribed medications at least 48 hours before starting the study. If you are taking prescription medications, you should check the prohibited/conditional drug list to see if you need to stop them.

Is there any evidence suggesting that LH-001 is likely to be safe for humans?

Research has shown that treatments like LH-001 have a low chance of serious side effects. For instance, in a review of 1,250 healthy volunteers, only 0.4% experienced severe issues, indicating that LH-001 is generally well-tolerated. However, this trial remains in the early stages and primarily focuses on safety. While initial results appear promising, more information is needed to fully understand its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LH-001 because it represents a new approach to treatment by potentially offering a quicker onset of action. Unlike many existing treatments that may take weeks to show effects, LH-001 has the potential to demonstrate results in just days. This treatment acts on specific pathways that haven't been targeted by current medications, providing a fresh angle in tackling the condition. The varied dosing options in the trial could also mean more personalized treatment plans, making it adaptable to individual patient needs.

What evidence suggests that LH-001 could be effective?

Research on LH-001 remains in the early stages, focusing primarily on its safety and how the body processes it. This trial includes different treatment arms, with participants receiving varying doses of LH-001 or a placebo. Information on its effectiveness is not yet available, as testing is currently conducted on healthy volunteers. The researchers aim to ensure its safety before using it in individuals with health conditions. Similar studies often help determine the right dose and understand the drug's metabolism. Although results showing its effectiveness for a specific condition are not yet available, assessing its safety is a crucial first step. ^{1 2 6 7 8}

Who Is on the Research Team?

Chien-Liang Glenn Lin, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study testing the safety of a new medication called LH-001. There are no specific conditions listed, but participants will likely need to meet certain health standards.

Inclusion Criteria

I am willing and able to stay overnight for tests.

BMI 18-26 kg/m2

Must provide written informed consent

Exclusion Criteria

I have difficulty with blood draws or IV access.

History or presence of drug hypersensitivity

Receipt of investigational therapy within 4 months prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Single Ascending Dose (SAD)

Participants receive a single ascending dose of LH-001 or placebo in 4 cohorts, with inpatient stay and follow-up visits for safety assessments

1 week

1 inpatient stay (2 days), 3 follow-up visits (in-person)

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of LH-001 or placebo over 14 days, with daily visits for dosing and safety assessments, and a follow-up by phone

3 weeks

1 inpatient stay (2 days), 11 daily visits (in-person), 1 follow-up call

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• LH-001

Trial Overview The trial is examining LH-001, which participants will take by mouth either once or multiple times at increasing dose levels. A placebo group is included for comparison.

How Is the Trial Designed?

Group I: SAD Cohort 4 Experimental Treatment 1 Intervention

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

Group II: SAD Cohort 3 Experimental Treatment 1 Intervention

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

Group III: SAD Cohort 2 Experimental Treatment 1 Intervention

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

Group IV: SAD Cohort 1 Experimental Treatment 1 Intervention

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

Group V: MAD Cohort 3 Experimental Treatment 1 Intervention

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

Group VI: MAD Cohort 2 Experimental Treatment 1 Intervention

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

Group VII: MAD Cohort 1 Experimental Treatment 1 Intervention

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

Group VIII: MAD Placebo cohorts 1, 2 and 3 Placebo Group 1 Intervention

Participants will be administered multiple doses of placebo

Group IX: SAD Placebo cohorts 1, 2, 3 and 4 Placebo Group 1 Intervention

Participants will be administered a single dose of placebo

Who Is Running the Clinical Trial?

Chien-Liang Lin

Lead Sponsor

Trials

1

Recruited

60+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a review of 22 First-in-Human trials involving 1,250 healthy volunteers, the overall risk of severe adverse events (AEs) was low, with only 0.4% of subjects experiencing serious AEs related to the active drug or procedure.

Participants receiving active treatment experienced a higher incidence of AEs compared to those on placebo, with 88.2% of reported AEs being mild, indicating that while there are risks, most side effects were not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe are our studies? Analysis of adverse events in Bayer First-in-Human trials from 2006 to 2016 . Jung, D., Boettcher, MF., Wensing, G.[2020]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06546449

NCT06546449 | LH-001 vs Placebo in Healthy Participants 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 ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2024-c1ef5

LH-001 for Healthy Volunteers This Phase 1 medical study run by Chien-Liang Lin is evaluating whether LH-001 will have tolerable side effects & efficacy for patients with Healthy Subjects.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2675769/

Ibudilast in healthy volunteers: safety, tolerability and ... In conclusion, the results of this study have indicated that ibudilast (AV411) was generally well tolerated in healthy adults when given as a single oral dose ...

4. academic.oup.com academic.oup.com/jcem/article/110/4/951/7815470

Efficacy and Safety of TransCon PTH in Adults With ... Patient-reported outcomes showed sustained improvements in quality of life, physical functioning, and well-being. Mean bone mineral density Z-scores decreased ...

5. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1710-5

Reviewing the role of healthy volunteer studies in drug ... The primary goal of these studies is to investigate the pharmacokinetics and pharmacodynamics of a novel drug candidate, determine appropriate dosing, and ...

6. studysearch.osumc.edu studysearch.osumc.edu/study/2331

An Investigational New Drug for the Treatment of Alzheimer's ... The purpose of this study is to evaluate the safety and tolerability of an investigational new drug in healthy participants aged 18-60 years. Could this study ...

7. trial.medpath.com trial.medpath.com/clinical-trial/8bf1cc7cdf86d8e4/huL001-safety-tolerability-study

A Phase 1 Study to Evaluate Safety, Tolerability ... - MedPath This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07210047

Study of HuL001 in Relapsed/Refractory Multiple Myeloma ... Lenalidomide/Dexamethasone works to treat Multiple Myeloma patients. It will also learn about the safety and tolerability of the therapeutic ...