Beijing AnDing Hospital Capital Medical University
Beijing, China
NCT Number: NCT06556966
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LY03020 for one single dose
Other names: LPM787000048 Maleate sustained-release tablet
Placebo for one single dose
Other names: Placebo of LPM787000048 Maleate sustained-release tablet
Time frame: up to144 hours
Percentage of adverse events
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Time frame: up to144 hours
One dose group will be selected for metabolite identification.
Luye Pharma Group Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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