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The primary purpose of this phase â… b/â…¡ 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.
This study consists of two stages: phase Ib and phase II. Primary objective of phase Ib Study is to assess the safety, tolerability of HS-10506 in subjects with insomnia disorder. .
Primary objective of phase II Study is to assess the efficacy of HS-10506 in subjects with insomnia disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10506, 10 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 10mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 10mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
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| HS-10506, 20 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 20mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 20mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
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| HS-10506, 40 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 40mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 40mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
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| HS-10506, 80 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 80mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 80mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10506 | Drug | HS-10506, tablets (10mg, 20mg, 40mg and 80mg) at night once daily from Day 1 to Day 5 in phase Ib study, and from Day 1 to Day 28 in phase II study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Baseline up to the end of the study (3 days after the last dose) or early withdrawal |
| Incidence and severity of serious adverse events (SAE) | An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Baseline up to the end of the study (3 days after the last dose) or early withdrawal |
| Changes in laboratory test before and after drug administration | Number of participants with clinically significant laboratory abnormalities, including complete blood cell count, urinalysis, serum chemistry, coagulation function were reported. | Baseline up to the end of the study (3 days after last dose) or early withdrawal |
| Changes in ECG before and after drug administration | Number of participants with clinically significant ECG abnormalities were reported. | Baseline up to the end of the study (3 days after last dose) or early withdrawal |
| Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration | The KSS is a patient-reported assessment of drowsiness level at the time of scale administration. | From start of the drug administration to the next day of the last dose or early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (C[max]) | The C[max] is the maximum observed plasma concentration and will be determined for HS-10506. | Baseline up to 48 hours after the last dose or early withdrawal |
| Time to reach the maximum plasma concentration (T[max]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo | Drug | Placebo, placebo tablets matching the HS-10506 tablets |
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| Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14 | LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. | Baseline, Night 13& Night 14 |
Time to reach maximum observed plasma concentration (T[max]) of HS-10506. |
| Baseline up to 48 hours after the last dose or early withdrawal |
| Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]) | Area under the concentration-time curve from time zero to last time of quantifiable concentration of HS-10506. | Baseline up to 48 hours after the last dose or early withdrawal |
| Terminal elimination half-life (t1/2) | Apparent terminal elimination half-life of HS-10506. | Baseline up to 48 hours after the last dose or early withdrawal |
| Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring | Latency to persistent sleep (LPS) is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep over PSG assessment. | Baseline and Night 5 |
| Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring | Wake After Sleep Onset (WASO) is defined as the duration of wakefulness from the onset of persistent sleep over the PSG assessment. | Baseline and Night 5 |
| Change from baseline in mean LPS measured by PSG | Latency to Persistent Sleep (LPS) is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep over PSG assessment. | Baseline up to 28 days. |
| Change from baseline in mean TST measured by PSG | Total sleep time (TST) is the total amount of sleep time scored during the total recording time over PSG assessment. | Baseline up to 28 days. |
| Change from baseline in mean WASO measured by PSG | Wake after initial sleep onset (WASO) is defined as the duration of wakefulness from the onset of persistent sleep over PSG assessment. | Baseline up to 28 days. |
| Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary | Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) measured by sleep diary. | Baseline up to 28 days. |
| Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary | Change from baseline in mean self-reported total sleep time measured by sleep diary. | Baseline up to 28 days. |
| Incidence and severity of adverse events (AE) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Baseline up to 28 days. |
| Incidence and severity of serious adverse events (SAE) | An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Baseline up to 28 days. |
| D001523 |
| Mental Disorders |