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

NCT04596007 | Completed Phase 1

• 1 other identifier: HEC83518-P-01 / CRC-C1934
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• PK parameters - AUC0-∞

  up to 96 hours

• PK parameters - Cmax

  up to 96 hours

• PK parameters -tmax

  up to 96 hours

• PK parameters -t½

  up to 96 hours

• PK parameters -Vz/F

  up to 96 hours

Other Outcomes (1)

• The pharmacodynamics of HEC83518 tablets

  up to 24 hours

Study Arms (2)

HEC83518 tablets

EXPERIMENTAL

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

placebo tablets

PLACEBO COMPARATOR

There will be a total of 6 dose cohorts: 10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg.

Drug: Placebo

Interventions

HEC83518 tablets DRUG

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.

HEC83518 tablets

Placebo DRUG

placebo

placebo tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who are willing and are able to provide a written informed consent to participate in the study.
• Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
• Subjects aged between 18 and 45 (both inclusive) years old.
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• Subjects with history of sleep-related illness.
• Subjects with history of severe involuntary hypoglycemia
• Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
• 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.
• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• Positive results from urine drug screen test.
• 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.
• Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
• Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
• Subjects who plan to receive or have had organ transplants.
• Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
• Subjects who participated in another clinical trial within 3 months prior to initial dosing.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The Shanghai xuhui district central hospital

Shanghai, Shanghai Municipality, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All are double-blind except the pre-trial group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: April 1, 2020
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: May 1, 2026

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)