Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
NCT Number: NCT05238701
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LPM3770164 sustained release tablet will be administrated orally single-dose on day 1
Other names: LY03015
LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1
Other names: LY03015 simulant
Time frame: from baseline to day 28
Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Time frame: from baseline to day 15
Time frame: from baseline to day 15
Time frame: from baseline to day 15
Time frame: from baseline to day 15
Time frame: from baseline to day 15
Time frame: from baseline to day 15
Time frame: baseline, day 3, day 8, day 15, day 28
Time frame: baseline, day 3, day 8, day 15, day 28
Time frame: baseline, day 15, day 28
Time frame: baseline, day 15, day 28
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Time frame: baseline, day 15, day 28
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Time frame: baseline, day 3, day 28
Time frame: baseline, day 3, day 28
Time frame: baseline, day 3, day 28
Time frame: baseline, day 3, day 28
Luye Pharma Group Ltd.
Industry
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy 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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