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

Last updated: May 6, 2021
Sponsor: Sunshine Lake Pharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Insomnia

Treatment

N/A

Clinical Study ID

NCT04667429
HEC83518-P-02 / CRC-C2048
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who are willing and are able to provide a written informed consent toparticipate in the study.
  2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout thetrial.
  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) andbody mass index ≥18 and ≤28 kg/m2 at screening.
  5. Subjects, who are healthy, as having no clinically significant abnormalities in vitalsigns, physical examination, clinical laboratory test results, Chest X-ray and 12-leadelectrocardiogram (ECG).

Exclusion

Exclusion Criteria:

  1. Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screeningor 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 TPantibodies at screening.
  3. Subjects with history of digestive system,urinary system, liver,central nervoussystem, blood system, endocrine system,respiratory system,immune system,cardiovascularsystem,and/or malignant tumor or others medical conditions (such as history of mentalillness, etc.) that are not suitable for clinical trial participation;Subjects withhistory of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, oracute 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 drugformulation(s) ,or anaphylaxis physique.
  7. Use of any prescription or non-prescription medications within 14 days prior toinitial dosing,or Use of any medications known to inhibit or induce cytochrome Penzyme drug metabolism within 28 days prior to initial dosing.
  8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruitwithin 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 asAlcohol 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 beforeadministration 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 forwomen of child-bearing potential. 15 Subjects who participated in another clinicaltrial within 3 months prior to initial dosing.

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

Study Design

Total Participants: 52
Study Start date:
January 18, 2021
Estimated Completion Date:
October 31, 2021

Connect with a study center

  • The Shanghai Xuhui Central Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

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