The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.
Participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);
Participants are required to voluntarily sign the informed consent form;
Body mass index (BMI): BMI (weight/height2 [kg/m2]) must be in the range of 18 to 35 kg/m2 (inclusive);
For Participants completed Study 301: Participants have completed the Study 301, can potentially benefit from extended treatment with HS-10506 and have no major safety risks according to the investigator's clinical judgment;
Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;
Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;
Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single/multi-target drugs within the past 2 weeks or 5 half-lives of the medication;
Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;
Single group
HS-10506
DrugHS-10506 tablet
Incidence and severity of adverse events (AE)
An AE 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.
Incidence and severity of serious adverse events (SAE)
An SAE is any 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 participants and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Incidence and severity of adverse events of special interest (AESI)
An AESI (serious or non-serious) is any medical event specific to the investigational product or clinical trial.
Number of Participants With Clinically Significant Change in hematology
Hematology tests will include hemoglobin, hematocrit, red blood cell count, platelets, white blood cell count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Any clinically significant change in hematological values will be determined at the investigator's discretion
Number of Participants With Clinically Significant Change in clinical chemistry
Clinical chemistry tests will include total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, albumin, total protein, creatinine, glucose, hemoglobin A1c (HbA1c), creatinine kinase. Any clinically significant change in clinical chemistry values will be determined at the investigator's discretion.
Number of Participants With Clinically Significant Change in urinalysis
Urinalysis will include glucose, ketones, urine red blood cells, urine white blood cells. Any clinically significant change in urinalysis values will be determined at the investigator's discretion.
Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20)
The PWC-20 is a 20-item questionnaire and the score of each item ranges from 0-3 (0=not present, 1=mild, 2=moderate, 3=severe) with higher scores indicating greater severity of withdrawal symptoms
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