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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04591301
Other study ID # HEC113995PA•H2O-P-01/CRC-C1910
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 4, 2019
Est. completion date December 6, 2019

Study information

Verified date October 2020
Source Sunshine Lake Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 6, 2019
Est. primary completion date December 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 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: - 1.Subjects with serum creatinine, ALT and AST levels =1.5 times of the upper limit of normal value at screening. - 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 epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma. - 4. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique. - 5. Use of any prescription or non-prescription medications within 14 days prior to initial dosing#Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing. - 6. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. - 7. Positive results from urine drug screen test. - 8. 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. - 9.Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study. - 10. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. - 11. Subjects who plan to receive or have had organ transplants. - 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.

Study Design


Intervention

Drug:
HEC113995 PA•H2O tablets
Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Placebo tablets
Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Locations

Country Name City State
China Shanghai Xuhui Central Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD up to 7 days
Secondary PK parameters - AUC0-8 area under the concentration versus time curve (AUC) from time zero to infinity up to 144 hours
Secondary PK parameters - Cmax Geometric Mean of Maximum Observed Plasma Concentration of HEC113995 PA•H2O up to 144 hours
Secondary PK parameters -tmax time to peak up to 144 hours
Secondary PK parameters -t½ apparent terminal elimination half-life up to 144 hours
Secondary PK parameters -Vz/F apparent volume of distribution up to 144 hours
Secondary PK parameters - MRT the Mean Residence Time up to 144 hours
Secondary PK parameters -CL/F the Apparent Clearance up to 144 hours
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