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

NCT ID: NCT04591301

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2019-12-06

Brief Summary

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

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HEC113995 PA•H2O 2.5mg

Healthy subjects are given HEC113995 PA•H2O 2.5 mg in a single dose.

Group Type: EXPERIMENTAL

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

HEC113995 PA•H2O 5mg

Healthy subjects are given HEC113995 PA•H2O 5 mg in a single dose.

Group Type: ACTIVE_COMPARATOR

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

HEC113995 PA•H2O 10mg

Healthy subjects are given HEC113995 PA•H2O 10 mg in a single dose.

Group Type: ACTIVE_COMPARATOR

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

HEC113995 PA•H2O 20mg

Healthy subjects are given HEC113995 PA•H2O 20 mg in a single dose.

Group Type: ACTIVE_COMPARATOR

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

HEC113995 PA•H2O 40mg

Healthy subjects are given HEC113995 PA•H2O 40 mg in a single dose.

Group Type: ACTIVE_COMPARATOR

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

HEC113995 PA•H2O 60mg

Healthy subjects are given HEC113995 PA•H2O 60 mg in a single dose.

Group Type: ACTIVE_COMPARATOR

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

HEC113995 PA•H2O 80mg

Healthy subjects are given HEC113995 PA•H2O 80 mg in a single dose.

Group Type: ACTIVE_COMPARATOR

HEC113995 PA•H2O tablets

Intervention Type: DRUG

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

placebo

Healthy subjects are given placebo in a single dose.

Group Type: PLACEBO_COMPARATOR

Placebo tablets

Intervention Type: DRUG

Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Interventions

HEC113995 PA•H2O tablets

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Intervention Type: DRUG

Placebo tablets

Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, , China

Countries

China

Other Identifiers

HEC113995PA•H2O-P-01/CRC-C1910

Identifier Type: -

Identifier Source: org_study_id