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

Phase 1

• Conditions: Insomnia
• Interventions: Drug: Placebo; Drug: HEC83518 tablets

• Registration Number: NCT04596007
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-09-10
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo tablets	Placebo	There will be a total of 6 dose cohorts: 10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg.
HEC83518 tablets	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Shanghai xuhui district central hospital; 🇨🇳 Shanghai, Shanghai, China