Clinical trial NCT06556966: A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Alzheimer's Disease Psychosis
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 subjects.

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 subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Frequency of adverse events (AEs)
timeFrame: up to144 hours
Secondary outcomes:
measure: Maximum observed concentration (Cmax) of LPM787000048 in plasma
timeFrame: up to144 hours
measure: Time to maximum observed concentration (Tmax) of LPM787000048 in plasma
timeFrame: up to144 hours
measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
timeFrame: up to144 hours
measure: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma
timeFrame: up to144 hours
measure: Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
timeFrame: up to144 hours
measure: Apparent volume of distribution（Vz/F） of LPM787000048 in plasma
timeFrame: up to144 hours
measure: Apparent total body clearance (CL/F) of LPM787000048 from plasma
timeFrame: up to144 hours
Other outcomes:
measure: Quantitatively determine the concentration of LPM787000048 and major metabolites (if applicable) in urine and calculate the cumulative excretion ratio in urine.
timeFrame: up to144 hours
Locations:
city: Beijing
country: China
facility: Beijing AnDing Hospital Capital Medical University
Study officials:
affiliation: Beijing AnDing Hospital Capital Medical University
name: Gang Wang
role: PRINCIPAL_INVESTIGATOR
References: