NCT06556966CompletedPhase 1
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
A Phase Ⅰ, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Study to Assess the Safety, Tolerability, and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet (LY03020) in Chinese Healthy Adult Subjects
Source: ClinicalTrials.gov · Last updated 29 May 2025
Brief summary (registry, in English)
This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 13 Aug 2024
- Start date
- 19 Aug 2024
- Primary completion date
- 13 Feb 2025
- Lead sponsor
- Luye Pharma Group Ltd.
- Diseases
- Schizophrenia, Alzheimer disease
- NCT number
- NCT06556966
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 66
- From 19 Aug 2024 to the primary completion date, 13 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
- Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
Other illness
- Subjects have any clinically significant medical condition or chronic disease.
- Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure,or angle-closure glaucoma.Subjects have a abnormal and clinically significant test for ophthalmic examination during screening.
- Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
- Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation
Lab values
- Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
- Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis serum reaction.
Who the study is looking for
- Subjects sign informed consent voluntarily.
- Male or female aged 18 to 45 years.
- Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (BMI).
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anding Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.