the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623814
• Other study ID #: HEC113995-P-04/CRC-C2006
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2020
• Est. completion date: August 12, 2020

Study information

• Verified date: November 2020
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• 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 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Food
HEC113995 20mg will be taken orally fasted or with food

Drug:
• HEC113995
HEC113995 will be taken orally fasted (HEC113995 10mg)or with food (HEC113995 20mg and 40mg) for 10 days
• placebo
The placebo will be administered fasted or with food for 10 days.

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	Adverse event	To assess the safety and tolerability of therapy	up to 34 days
Secondary	Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-8 )		up to 120 hours
Secondary	Maximum Plasma Concentration ( Cmax)		up to 120 hours
Secondary	Time to peak(tmax)		up to 120 hours
Secondary	Apparent terminal elimination half-life(t½)		up to 120 hours
Secondary	Apparent volume of distribution(Vz/F)		up to 120 hours
Secondary	The Mean Residence Time( MRT)		up to 120 hours
Secondary	The Apparent Clearance (CL/F)		up to 120 hours
Secondary	The Accumulation Ratio(R)		up to 120 hours
Secondary	Food Effect on the Cmax		up to 120 hours
Secondary	Food Effect on the AUC		up to 120 hours