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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: HEC113995 PA•H2O tablets; Drug: Placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEC113995 PA•H2O 2.5mg; Healthy subjects are given HEC113995 PA•H2O 2.5 mg in a single dose.	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.
Active Comparator: HEC113995 PA•H2O 5mg; Healthy subjects are given HEC113995 PA•H2O 5 mg in a single dose.	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.
Active Comparator: HEC113995 PA•H2O 10mg; Healthy subjects are given HEC113995 PA•H2O 10 mg in a single dose.	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.
Active Comparator: HEC113995 PA•H2O 20mg; Healthy subjects are given HEC113995 PA•H2O 20 mg in a single dose.	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.
Active Comparator: HEC113995 PA•H2O 40mg; Healthy subjects are given HEC113995 PA•H2O 40 mg in a single dose.	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.
Active Comparator: HEC113995 PA•H2O 60mg; Healthy subjects are given HEC113995 PA•H2O 60 mg in a single dose.	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.
Active Comparator: HEC113995 PA•H2O 80mg; Healthy subjects are given HEC113995 PA•H2O 80 mg in a single dose.	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 Comparator: placebo; Healthy subjects are given placebo in a single dose.	Drug: Placebo tablets; Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters - AUC0-∞	area under the concentration versus time curve (AUC) from time zero to infinity	up to 144 hours
PK parameters - Cmax	Geometric Mean of Maximum Observed Plasma Concentration of HEC113995 PA•H2O	up to 144 hours
PK parameters -tmax	time to peak	up to 144 hours
PK parameters -t½	apparent terminal elimination half-life	up to 144 hours
PK parameters -Vz/F	apparent volume of distribution	up to 144 hours
PK parameters - MRT	the Mean Residence Time	up to 144 hours
PK parameters -CL/F	the Apparent Clearance	up to 144 hours

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: HEC113995PA•H2O-P-01/CRC-C1910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No