A Study of LY03015 in Healthy Chinese and Caucasian Adult Subjects

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT07671833
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • LY03015 (LPM3770164 extended-release tablets) — DRUG
    LY03015 (LPM3770164) is an investigational extended-release tablet administered. LY03015, a new generation dual-target drug is a selective VMAT2 inhibitor and sigma-1 receptor.

Study Details

This is an open-label, single-dose, parallel-group study to evaluate the safety, tolerability and pharmacokinetic characteristics of LY03015 in healthy Chinese and Caucasian adult subjects. The duration of study will be around up to 42 days for each participant, including up to 14 days of screening period, baseline visit, and a 28-day safety assessment period with a 7-day/6-night stay in the clinical research unit.

Key Dates

First listed
Jun 26, 2026
Start date
Apr 15, 2026
Status verified
Jun 2026
Primary completion
May 8, 2026
Completion
May 27, 2026

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Chinese healthy participants
    A single dose of 20 mg LY03015 administered on Day 1.
  • Experimental: Caucasian healthy participants
    A single dose level of 20 mg orally administered on Day 1

Primary Outcome Measure

Pharmacokinetic profile of LY03015 [ Time Frame: 15 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience Research, LLC.Los AlamitosCalifornia90720-

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Collaborative Neuroscience Research, LLC.· Los Alamitos, CA

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