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

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: HEC113995 PA•H2O tablets; Drug: Placebo tablets

• Registration Number: NCT04591301
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-04
• Primary Completion: 2019-12-06
• Study Completion: 2019-12-06
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC113995 PA•H2O 10mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 10 mg in a single dose.
HEC113995 PA•H2O 20mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 20 mg in a single dose.
HEC113995 PA•H2O 60mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 60 mg in a single dose.
HEC113995 PA•H2O 5mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 5 mg in a single dose.
HEC113995 PA•H2O 80mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 80 mg in a single dose.
HEC113995 PA•H2O 2.5mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 2.5 mg in a single dose.
HEC113995 PA•H2O 40mg	HEC113995 PA•H2O tablets	Healthy subjects are given HEC113995 PA•H2O 40 mg in a single dose.
placebo	Placebo tablets	Healthy subjects are given placebo in a single dose.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose	up to 7 days	To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, China