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

Major Depressive Disorder Clinical Trial

Official title:

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of HEC113995 PA•H2O Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591301
• Other study ID #: HEC113995PA•H2O-P-01/CRC-C1910
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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