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

Sunshine Lake Pharma

Status and phase: Unknown; Phase 1

Conditions: Insomnia

Treatments: Drug: HEC83518; Other: Food; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04667429

HEC83518-P-02 / CRC-C2048

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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52 participants in 5 patient groups, including a placebo group

Food effect

Experimental group

Description:

HEC83518 40mg will be administered fasted, or with high-fat meal for once.

Treatment:

Other: Food

Multiple Ascending Doses-HEC83518 20mg

Experimental group

Description:

HEC83518 20mg will be administered before sleep for 15 days .

Treatment:

Drug: HEC83518

Multiple Ascending Doses-HEC83518 40mg

Experimental group

Description:

HEC83518 40mg will be administered before sleep for 15 days .

Treatment:

Drug: HEC83518

Multiple Ascending Doses-HEC83518 80mg

Experimental group

Description:

HEC83518 80mg will be administered before sleep for 15 days .

Treatment:

Drug: HEC83518

Multiple Ascending Doses-placebo

Placebo Comparator group

Description:

Placebo will be administered before sleep for 15 days .

Treatment:

Drug: placebo