Status:
COMPLETED
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
Lead Sponsor:
Luye Pharma Group Ltd.
Conditions:
Schizophrenia
Alzheimer's Disease Psychosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 sub...
Detailed Description
The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subj...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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 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 any clinically significant abnormal vital signs, laboratory values, and ECGs.
- Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
- Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation
- Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis serum reaction.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06556966
Start Date
August 19 2024
End Date
February 13 2025
Last Update
May 29 2025
Active Locations (1)
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1
Beijing AnDing Hospital Capital Medical University
Beijing, China