the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects

Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Other: Food; Drug: HEC83518; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • The Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
2. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
3. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
4. Subjects with history of sleep-related illness.
5. Subjects with history of severe involuntary hypoglycemia
6. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
7. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
9. Positive results from urine drug screen test.
10. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
11. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
12. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
13. Subjects who plan to receive or have had organ transplants.
14. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 15 Subjects who participated in another clinical trial within 3 months prior to initial dosing.

16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food effect; HEC83518 40mg will be administered fasted, or with high-fat meal for once.	Other: Food; HEC83518 40mg will be taken orally fasted or with food
Experimental: Multiple Ascending Doses-HEC83518 20mg; HEC83518 20mg will be administered before sleep for 15 days .	Drug: HEC83518; HEC83518 will be taken orally before sleep for 15 days
Experimental: Multiple Ascending Doses-HEC83518 40mg; HEC83518 40mg will be administered before sleep for 15 days .	Drug: HEC83518; HEC83518 will be taken orally before sleep for 15 days
Experimental: Multiple Ascending Doses-HEC83518 80mg; HEC83518 80mg will be administered before sleep for 15 days .	Drug: HEC83518; HEC83518 will be taken orally before sleep for 15 days
Placebo Comparator: Multiple Ascending Doses-placebo; Placebo will be administered before sleep for 15 days .	Drug: placebo; The placebo will be administered before sleep for 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	To assess the safety and tolerability of therapy	up to 34 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )	up to 72 hours
Maximum Plasma Concentration ( Cmax)	up to 72 hours
Time to peak(tmax)	up to 72 hours
Apparent terminal elimination half-life(t½)	up to 72 hours
Apparent volume of distribution(Vz/F)	up to 72 hours
The Mean Residence Time#(MRT)	up to 72 hours
The Apparent Clearance (CL/F)	up to 72 hours
The Accumulation Ratio(R)	up to 60 hours
Food Effect on the Cmax	up to 72 hours
Food Effect on the AUC	up to 72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karolinska sleepiness Scale（KSS）	This is a 9-point scale (1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy,7 = sleepy - but no difficulty remaining awake,and 9 = extremely sleepy - fighting sleep).The score of KSS scale will be recorded at different time and the change score compared with baseline will be analysed to evaluated the start of effective time, the most effective time and the recovered time to baseline.	up to 24 hour
Latency to sleep measured by a polysomnograph		during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Wake After Sleep Onset measured by a polysomnograph		during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Total sleep time measured by a polysomnograph		during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Sleep efficiency measured by a polysomnograph		during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): July 9, 2021

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Food
• Other Study ID Numbers: HEC83518-P-02 / CRC-C2048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No