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

NCT04591301 | Completed Phase 1

• 1 other identifier: HEC113995PA•H2O-P-01/CRC-C1910
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of HEC113995 PA•H2O by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose

  To investigate the safety and tolerability of HEC113995 PA•H2O by assessment of AEs (non-serious and serious) following administration in SAD

  up to 7 days

Secondary Outcomes (7)

• PK parameters - AUC0-∞

  up to 144 hours

• PK parameters - Cmax

  up to 144 hours

• PK parameters -tmax

  up to 144 hours

• PK parameters -t½

  up to 144 hours

• PK parameters -Vz/F

  up to 144 hours

Study Arms (8)

HEC113995 PA•H2O 2.5mg

EXPERIMENTAL

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

Drug: HEC113995 PA•H2O tablets

HEC113995 PA•H2O 5mg

ACTIVE COMPARATOR

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

Drug: HEC113995 PA•H2O tablets

HEC113995 PA•H2O 10mg

ACTIVE COMPARATOR

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

Drug: HEC113995 PA•H2O tablets

HEC113995 PA•H2O 20mg

ACTIVE COMPARATOR

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

Drug: HEC113995 PA•H2O tablets

HEC113995 PA•H2O 40mg

ACTIVE COMPARATOR

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

Drug: HEC113995 PA•H2O tablets

HEC113995 PA•H2O 60mg

ACTIVE COMPARATOR

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

Drug: HEC113995 PA•H2O tablets

HEC113995 PA•H2O 80mg

ACTIVE COMPARATOR

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

Drug: HEC113995 PA•H2O tablets

placebo

PLACEBO COMPARATOR

Healthy subjects are given placebo in a single dose.

Drug: Placebo tablets

Interventions

HEC113995 PA•H2O tablets 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; HEC113995 PA•H2O 2.5mg; HEC113995 PA•H2O 20mg; HEC113995 PA•H2O 40mg; HEC113995 PA•H2O 5mg; HEC113995 PA•H2O 60mg; HEC113995 PA•H2O 80mg

Placebo tablets DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Subjects who are willing and are able to provide a written informed consent to participate in the study.
• \. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
• \. Subjects aged between 18 and 45 (both inclusive) years old.
• \. 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.
• \. 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).

You may not qualify if:

• Subjects with serum creatinine, ALT and AST levels ≥1.5 times of the upper limit of normal value at screening.
• 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.
• \. 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.
• \. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique.
• \. 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.
• \. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• \. Positive results from urine drug screen test.
• \. 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.
• 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.
• \. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
• \. Subjects who plan to receive or have had organ transplants.
• \. Subjects who participated in another clinical trial within 3 months prior to initial dosing.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: July 4, 2019
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

CN (1)