the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: HEC113995; Other: Food; Drug: placebo

• Registration Number: NCT04623814
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-30
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Study First Submitted: 2020-10-19
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Last Update Submitted: 2020-11-24
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Ascending Doses-HEC113995 20mg	HEC113995	HEC113995 20mg will be administered with food for 10 days
Food effect	Food	HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once.
Multiple Ascending Doses-HEC113995 10mg	HEC113995	HEC113995 10mg will be administered fasted for 10 days
Multiple Ascending Doses-HEC113995 40mg	HEC113995	HEC113995 40mg will be administered with food for 10 days
Multiple Ascending Doses-placebo	placebo	Placebo arms will be administered fasted or with food for 10 days

Primary Outcome Measures

Name	Time	Method
Adverse event	up to 34 days	To assess the safety and tolerability of therapy

Secondary Outcome Measures

Name	Time	Method
Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )	up to 120 hours
Apparent terminal elimination half-life（t½）	up to 120 hours
Time to peak（tmax）	up to 120 hours
The Mean Residence Time（ MRT）	up to 120 hours
The Accumulation Ratio（R）	up to 120 hours
Maximum Plasma Concentration （ Cmax）	up to 120 hours
Apparent volume of distribution（Vz/F）	up to 120 hours
The Apparent Clearance （CL/F）	up to 120 hours
Food Effect on the Cmax	up to 120 hours
Food Effect on the AUC	up to 120 hours

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, China