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

Trial Summary

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.

What safety data exists for LH-001 in humans?

The available research discusses safety in general for first-in-human trials and phase I studies, highlighting the importance of structured risk assessments and the use of a national data bank to improve safety for healthy volunteers. However, there is no specific safety data for LH-001 mentioned in the provided articles. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Chien-Liang Glenn Lin, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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.

I have been treated for a major psychiatric illness.

Clinically significant findings in the opinion of the investigator in the laboratory, physical examination, or vital sign assessments

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

How safe are our studies? Analysis of adverse events in Bayer First-in-Human trials from 2006 to 2016 . [2020]

2. England pubmed.ncbi.nlm.nih.gov

Healthy volunteers data bank: where and how? [2004]

3. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Structured Risk Assessment for First-in-Human Studies. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings. [2022]