Clinical trial NCT04623814: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Adverse event
timeFrame: up to 34 days
Secondary outcomes:
measure: Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )
timeFrame: up to 120 hours
measure: Maximum Plasma Concentration （ Cmax）
timeFrame: up to 120 hours
measure: Time to peak（tmax）
timeFrame: up to 120 hours
measure: Apparent terminal elimination half-life（t½）
timeFrame: up to 120 hours
measure: Apparent volume of distribution（Vz/F）
timeFrame: up to 120 hours
measure: The Mean Residence Time（ MRT）
timeFrame: up to 120 hours
measure: The Apparent Clearance （CL/F）
timeFrame: up to 120 hours
measure: The Accumulation Ratio（R）
timeFrame: up to 120 hours
measure: Food Effect on the Cmax
timeFrame: up to 120 hours
measure: Food Effect on the AUC
timeFrame: up to 120 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
Study officials:
References: