protocolSection identificationModule nctId: NCT06279286, orgStudyIdInfo id: HS-10506-201, briefTitle: Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder., conditionsModule conditions: Insomnia Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: HS-10506, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AE), primaryOutcomes measure: Incidence and severity of serious adverse events (SAE), primaryOutcomes measure: Changes in laboratory test before and after drug administration, primaryOutcomes measure: Changes in ECG before and after drug administration, primaryOutcomes measure: Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration, primaryOutcomes measure: Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14, secondaryOutcomes measure: The maximum plasma concentration (C[max]), secondaryOutcomes measure: Time to reach the maximum plasma concentration (T[max]), secondaryOutcomes measure: Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]), secondaryOutcomes measure: Terminal elimination half-life (t1/2), secondaryOutcomes measure: Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring, secondaryOutcomes measure: Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring, secondaryOutcomes measure: Change from baseline in mean LPS measured by PSG, secondaryOutcomes measure: Change from baseline in mean TST measured by PSG, secondaryOutcomes measure: Change from baseline in mean WASO measured by PSG, secondaryOutcomes measure: Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary, secondaryOutcomes measure: Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary, secondaryOutcomes measure: Incidence and severity of adverse events (AE), secondaryOutcomes measure: Incidence and severity of serious adverse events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xuanwu Hospital Capital Medical University, city: Beijing, country: China, contacts name: yuping Wang, PhD, role: CONTACT, email: wangyuping01@sina.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False