Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder

NCT06279286 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10506-201
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia Disorder

Keywords

Clinical trial; insomnia disorder; phase Ⅰb/Ⅱ

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (13)

• The maximum plasma concentration (C[max])

  Baseline up to 48 hours after the last dose or early withdrawal

• Time to reach the maximum plasma concentration (T[max])

  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])

  Baseline up to 48 hours after the last dose or early withdrawal

• Terminal elimination half-life (t1/2)

  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

  Baseline and Night 5

Study Arms (4)

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.

Drug: HS-10506; Drug: Placebo

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.

Drug: HS-10506; Drug: Placebo

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.

Drug: HS-10506; Drug: Placebo

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.

Drug: HS-10506; Drug: Placebo

Interventions

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.

HS-10506, 10 milligram (mg) and placebo; HS-10506, 20 milligram (mg) and placebo; HS-10506, 40 milligram (mg) and placebo; HS-10506, 80 milligram (mg) and placebo

Placebo DRUG

Placebo, placebo tablets matching the HS-10506 tablets

HS-10506, 10 milligram (mg) and placebo; HS-10506, 20 milligram (mg) and placebo; HS-10506, 40 milligram (mg) and placebo; HS-10506, 80 milligram (mg) and placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be 18 to 64 years of age, inclusive
• Subjects are required to voluntarily sign the informed consent form;
• Body mass index (BMI): for phase Ib, males must weigh at least 50 kilogram (kg), females at least 45 kg, and BMI (weight/height2 \[kg/m2\]) must be in the range of 18 to 30 kg/m2 (inclusive) for both gender; for phase II, BMI must be in the range of 18 to 35 kg/m2 (inclusive);
• Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
• Participants must have Insomnia Severity Index (ISI) scores \>=15 at screening and baseline;
• Subjective sleep assessment: for phase Ib, subjects must have a self-reported sleep latency (sSOL) \>= 30 minutes, a subjective sleep awakening time (sWASO) \>= 30 minutes, and a subjective total sleep time (sTST) =\< 6.5 hours using the sleep diary for at least three nights every week in the last 1 month prior to screening; For phase II, subjects must have an sSOL \>= 30 minutes, sWASO \>= 30 minutes, and sTST =\< 6.5 hours for at least three nights every week within one month prior to screening; and sSOL \>= 30 minutes, sWASO \>= 30 minutes, and sTST =\< 6.5 hours for at least 3 nights from sleep diary in the last 7 days;
• PSG: for phase Ib, participants must demonstrate an LPS \>= 20 minutes, TST \< 420 minutes, and WASO \>= 30 minutes at screening; for phase II, participants must demonstrate a 2-night mean LPS \>= 30 minutes with neither night \< 20 minutes, a 2-night mean TST =\< 6.5 hours with neither night \> 7 hours and a 2-night mean WASO \>= 30 minutes with neither nigh \< 20 minutes.

You may not qualify if:

• Has history of or current sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;
• Has a hypopnea index (AHI) \>10 times/hour or periodic leg movement index (PLMI) \>10 times/hour monitored by PSG at screening or run-in period;
• Has history of or current neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or clinically significant and/or unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;
• (For phase II only) Has a Hamilton Anxiety Scale (HAMA) score \>= 14 or Hamilton Depression Scale (HAMD-17) score \>= 18;
• Use of any medication that may affect the pharmacokinetics of HS-10506 within the past 2 weeks or 5 half-lives of the medication;
• Use of 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;
• 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;
• Working across 3 or more time zones or shift work within 2 weeks prior to screening;
• Regularly naps more than 3 naps per week for \> 1 hour each time within the past 2 weeks prior to screening;
• 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;
• Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 28, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-02

Locations

CN (1)