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the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Food

HEC113995

placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Shanghai Xuhui Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Food effect

Multiple Ascending Doses-HEC113995 10mg

Multiple Ascending Doses-HEC113995 20mg

Multiple Ascending Doses-HEC113995 40mg

Multiple Ascending Doses-placebo

Arm Description

HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once.

HEC113995 10mg will be administered fasted for 10 days

HEC113995 20mg will be administered with food for 10 days

HEC113995 40mg will be administered with food for 10 days

Placebo arms will be administered fasted or with food for 10 days

Outcomes

Primary Outcome Measures

Adverse event

To assess the safety and tolerability of therapy

Secondary Outcome Measures

Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )

Maximum Plasma Concentration （ Cmax）

Time to peak（tmax）

Apparent terminal elimination half-life（t½）

Apparent volume of distribution（Vz/F）

The Mean Residence Time（ MRT）

The Apparent Clearance （CL/F）

The Accumulation Ratio（R）

Food Effect on the Cmax

Food Effect on the AUC

Full Information

NCT ID

NCT04623814

First Posted

October 19, 2020

Last Updated

November 24, 2020

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04623814

Brief Title

the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Official Title

HEC113995-A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study in Healthy Chinese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 30, 2020 (Actual)

Primary Completion Date

August 12, 2020 (Actual)

Study Completion Date

August 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Food effect

Arm Type

Experimental

Arm Description

HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once.

Arm Title

Multiple Ascending Doses-HEC113995 10mg

Arm Type

Experimental

Arm Description

HEC113995 10mg will be administered fasted for 10 days

Arm Title

Multiple Ascending Doses-HEC113995 20mg

Arm Type

Experimental

Arm Description

HEC113995 20mg will be administered with food for 10 days

Arm Title

Multiple Ascending Doses-HEC113995 40mg

Arm Type

Experimental

Arm Description

HEC113995 40mg will be administered with food for 10 days

Arm Title

Multiple Ascending Doses-placebo

Arm Type

Placebo Comparator

Arm Description

Placebo arms will be administered fasted or with food for 10 days

Intervention Type

Other

Intervention Name(s)

Food

Intervention Description

HEC113995 20mg will be taken orally fasted or with food

Intervention Type

Drug

Intervention Name(s)

HEC113995

Intervention Description

HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

The placebo will be administered fasted or with food for 10 days.

Primary Outcome Measure Information:

Title

Adverse event

Description

To assess the safety and tolerability of therapy

Time Frame

up to 34 days

Secondary Outcome Measure Information:

Title

Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )

Time Frame

up to 120 hours

Title

Maximum Plasma Concentration （ Cmax）

Time Frame

up to 120 hours

Title

Time to peak（tmax）

Time Frame

up to 120 hours

Title

Apparent terminal elimination half-life（t½）

Time Frame

up to 120 hours

Title

Apparent volume of distribution（Vz/F）

Time Frame

up to 120 hours

Title

The Mean Residence Time（ MRT）

Time Frame

up to 120 hours

Title

The Apparent Clearance （CL/F）

Time Frame

up to 120 hours

Title

The Accumulation Ratio（R）

Time Frame

up to 120 hours

Title

Food Effect on the Cmax

Time Frame

up to 120 hours

Title

Food Effect on the AUC

Time Frame

up to 120 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Shanghai Xuhui Central Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

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