The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC83518 Tablets in Chinses Healthy Subjects

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Drug: Placebo; Drug: HEC83518 tablets

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • The Shanghai xuhui district central hospital
      • Contact: YanMei Liu, Doctor; Phone Number: 021-54030254; Email: ymliu@shxh-centerlab.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plann 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 has 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 positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
2. 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.
3. Subjects with history of sleep-related illness.
4. Subjects with history of severe involuntary hypoglycemia
5. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
6. 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.
7. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
8. Positive results from urine drug screen test.
9. 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.
10. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
11. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
12. Subjects who plan to receive or have had organ transplants.
13. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
14. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
15. 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: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEC83518 tablets; There will be a total of 7 dose cohorts: 5 mg,10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg.	Drug: HEC83518 tablets; Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Placebo Comparator: placebo tablets; There will be a total of 6 dose cohorts: 10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg.	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Adverse Events (AEs)	Safety and Tolerability of HEC83518 by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose .	up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters - AUC0-∞	area under the concentration versus time curve (AUC) from time zero to infinity	up to 96 hours
PK parameters -t½	apparent terminal elimination half-life	up to 96 hours
PK parameters -Vz/F	apparent volume of distribution	up to 96 hours
PK parameters - MRT	the Mean Residence Time	up to 96 hours
PK parameters -CL/F	the Apparent Clearance	up to 96 hours
PK parameters - Cmax	Geometric Mean of Maximum Observed Plasma Concentration of HEC83518	up to 96 hours
PK parameters -tmax	time to peak	up to 96 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pharmacodynamics of HEC83518 tablets	The pharmacodynamics of HEC83518 was preliminarily explored through KSS (Karolinska sleepiness Scale, Karolinska Sleepiness Scale) and sleep monitoring instrument	up to 24 hours

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): September 10, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HEC83518-P-01 / CRC-C1934

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