LH-001 vs Placebo in Healthy Participants

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Chien-Liang Lin
Study ID
NCT06546449
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • LH-001 — DRUG
    LH-001 will be administered oral
  • Placebo — DRUG
    Placebo will be administered oral

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD Cohort 1
    Participants will be administered a single 12.5 mg dose of LH-001
  • Experimental: SAD Cohort 2
    Participants will be administered a single 25 mg dose of LH-001
  • Experimental: SAD Cohort 3
    Participants will be administered a single 50 mg dose of LH-001
  • Experimental: SAD Cohort 4
    Participants will be administered a single 100 mg dose of LH-001
  • Experimental: MAD Cohort 1
    Participants will be administered multiple 25 mg doses of LH-001
  • Experimental: MAD Cohort 2
    Participants will be administered multiple 50 mg doses of LH-001
  • Experimental: MAD Cohort 3
    Participants will be administered multiple 100 mg doses of LH-001
  • Placebo Comparator: SAD Placebo cohorts 1, 2, 3 and 4
    Participants will be administered a single dose of placebo
  • Placebo Comparator: MAD Placebo cohorts 1, 2 and 3
    Participants will be administered multiple doses of placebo

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43221
Sydney Harmon
[email protected]
614-685-8660
Cassandra Heslin
[email protected]
Douglas Scharre, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Ohio State University· Columbus, OH

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