HealthyPhase 1NCT06546449
LH-001 vs Placebo in Healthy Participants
A Phase 1 study testing LH-001 in people with Healthy, run by Chien-Liang Lin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LH-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
cassandra Heslin contact
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43221
Sydney Harmon, 614-685-8660, Sydney.Harmon@osumc.edu
Cassandra Heslin, Cassandra.Heslin@osumc.edu
About this study
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
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- LH-001, Placebo
- Keywords
- LH-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LH-001Drug
LH-001 will be administered oral
PlaceboDrug
Placebo will be administered oral
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | Participants will be administered a single 12.5 mg dose of LH-001 Receives: Drug: LH-001 |
| SAD Cohort 2 | Experimental | Participants will be administered a single 25 mg dose of LH-001 Receives: Drug: LH-001 |
| SAD Cohort 3 | Experimental | Participants will be administered a single 50 mg dose of LH-001 Receives: Drug: LH-001 |
| SAD Cohort 4 | Experimental | Participants will be administered a single 100 mg dose of LH-001 Receives: Drug: LH-001 |
| MAD Cohort 1 | Experimental | Participants will be administered multiple 25 mg doses of LH-001 Receives: Drug: LH-001 |
| MAD Cohort 2 | Experimental | Participants will be administered multiple 50 mg doses of LH-001 Receives: Drug: LH-001 |
| MAD Cohort 3 | Experimental | Participants will be administered multiple 100 mg doses of LH-001 Receives: Drug: LH-001 |
| SAD Placebo cohorts 1, 2, 3 and 4 | Placebo comparator | Participants will be administered a single dose of placebo Receives: Drug: Placebo |
| MAD Placebo cohorts 1, 2 and 3 | Placebo comparator | Participants will be administered multiple doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who experience at least one treatment-emergent AE
Measured: 8 days for SAD and 21 days for MAD
Percentage of participants who discontinue due to an AE
Measured: 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
Measured: 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
Measured: 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
Measured: 8 days for SAD and 21 days for MAD
Secondary outcomes (4)
Maximum concentration (Cmax)
Measured: Day 1 for all cohorts and Day 14 for MAD cohorts
Time to reach maximum concentration (Tmax)
Measured: 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)
Measured: 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)
Measured: Day 1 for all cohorts and Day 14 for MAD cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start5 May 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chien-Liang Lin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Chien-Liang Lin, Ohio State University
- Investigators
- Chien-Liang Glenn Lin, PhD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546449
- Sponsor's protocol ID
- 2024W0061
- Other IDs
- 1U01AG068822-01
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06546449
- Acronym / sponsor ID
- 2024W0061
- Conditions
- Healthy
- Keywords
- LH-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chien-Liang LinUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: LH-001Participants will be administered a single 12.5 mg dose of LH-001 |
| SAD Cohort 2 | Experimental | Drug: LH-001Participants will be administered a single 25 mg dose of LH-001 |
| SAD Cohort 3 | Experimental | Drug: LH-001Participants will be administered a single 50 mg dose of LH-001 |
| SAD Cohort 4 | Experimental | Drug: LH-001Participants will be administered a single 100 mg dose of LH-001 |
| MAD Cohort 1 | Experimental | Drug: LH-001Participants will be administered multiple 25 mg doses of LH-001 |
| MAD Cohort 2 | Experimental | Drug: LH-001Participants will be administered multiple 50 mg doses of LH-001 |
| MAD Cohort 3 | Experimental | Drug: LH-001Participants will be administered multiple 100 mg doses of LH-001 |
| SAD Placebo cohorts 1, 2, 3 and 4 | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of placebo |
| MAD Placebo cohorts 1, 2 and 3 | Placebo comparator | Drug: PlaceboParticipants will be administered multiple doses of placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LH-001LH-001 will be administered oral | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4 |
| PlaceboPlacebo will be administered oral | Drug | MAD Placebo cohorts 1, 2 and 3, SAD Placebo cohorts 1, 2, 3 and 4 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
cassandra Heslin contact
Chien-Liang Glenn Lin, PhD study director
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LH-001 in people with Healthy, run by Chien-Liang Lin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney E Harmon (614-685-8660, Sydney.Harmon@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.