CompletedPhase 1

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

China57 participantsStarted 2021-01-18

Plain-language summary

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

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
✕. 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.

Adverse event

Timeframe: up to 34 days

NCT IDNCT04667429

SponsorSunshine Lake Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-09

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
✕. 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.