the Safety, Tolerability, and Pharmacokinetics Study of HEC113995
NCT ID: NCT04623814
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2020-03-30
2020-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Food effect
HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once.
Food
HEC113995 20mg will be taken orally fasted or with food
Multiple Ascending Doses-HEC113995 10mg
HEC113995 10mg will be administered fasted for 10 days
HEC113995
HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
Multiple Ascending Doses-HEC113995 20mg
HEC113995 20mg will be administered with food for 10 days
HEC113995
HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
Multiple Ascending Doses-HEC113995 40mg
HEC113995 40mg will be administered with food for 10 days
HEC113995
HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
Multiple Ascending Doses-placebo
Placebo arms will be administered fasted or with food for 10 days
placebo
The placebo will be administered fasted or with food for 10 days.
Interventions
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Food
HEC113995 20mg will be taken orally fasted or with food
HEC113995
HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
placebo
The placebo will be administered fasted or with food for 10 days.
Eligibility Criteria
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Inclusion Criteria
* 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 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
* 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 epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
* 3\. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
* 4\. 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.
* 5\. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
* 6\. Positive results from urine drug screen test.
* 7\. 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.
* 8\. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
* 9\. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
* 10\. Subjects who plan to receive or have had organ transplants.
* 11\. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
* 12\. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
* 13\. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
18 Years
45 Years
ALL
Yes
Sponsors
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Sunshine Lake Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Xuhui Central Hospital
Shanghai, , China
Countries
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Other Identifiers
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HEC113995-P-04/CRC-C2006
Identifier Type: -
Identifier Source: org_study_id