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CompletedNCT04591301Updated Oct 28, 2020

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

A Phase 1 interventional study of HEC113995 PA•H2O tablets and Placebo tablets in Major Depressive Disorder, sponsored by Sunshine Lake Pharma Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-28.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 2019, registered Oct 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 69 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
    1. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
    1. Subjects aged between 18 and 45 (both inclusive) years old.
    1. 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.
    1. 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

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.
    1. 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.
    1. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique.
    1. 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.
    1. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
    1. Positive results from urine drug screen test.
    1. 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.
    1. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
    1. Subjects who plan to receive or have had organ transplants.
    1. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
    1. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    HEC113995 PA•H2O 2.5mg

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

    Drug: HEC113995 PA•H2O tablets

  • Active comparator
    HEC113995 PA•H2O 5mg

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

    Drug: HEC113995 PA•H2O tablets

  • Active comparator
    HEC113995 PA•H2O 10mg

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

    Drug: HEC113995 PA•H2O tablets

  • Active comparator
    HEC113995 PA•H2O 20mg

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

    Drug: HEC113995 PA•H2O tablets

  • Active comparator
    HEC113995 PA•H2O 40mg

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

    Drug: HEC113995 PA•H2O tablets

  • Active comparator
    HEC113995 PA•H2O 60mg

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

    Drug: HEC113995 PA•H2O tablets

  • Active comparator
    HEC113995 PA•H2O 80mg

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

    Drug: HEC113995 PA•H2O tablets

  • Placebo comparator
    placebo

    Healthy subjects are given placebo in a single dose.

    Drug: Placebo tablets

Interventions

  • DrugHEC113995 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.

  • DrugPlacebo tablets

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

06

What researchers measure

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

    Time frame: up to 7 days

Secondary outcomes

  1. PK parameters - AUC0-∞

    area under the concentration versus time curve (AUC) from time zero to infinity

    Time frame: up to 144 hours

  2. PK parameters - Cmax

    Geometric Mean of Maximum Observed Plasma Concentration of HEC113995 PA•H2O

    Time frame: up to 144 hours

  3. PK parameters -tmax

    time to peak

    Time frame: up to 144 hours

  4. PK parameters -t½

    apparent terminal elimination half-life

    Time frame: up to 144 hours

  5. PK parameters -Vz/F

    apparent volume of distribution

    Time frame: up to 144 hours

  6. PK parameters - MRT

    the Mean Residence Time

    Time frame: up to 144 hours

  7. PK parameters -CL/F

    the Apparent Clearance

    Time frame: up to 144 hours

07

Study locations

1 site
  • Shanghai Xuhui Central Hospital
    Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04591301
Lead sponsor
Sunshine Lake Pharma Co., Ltd.
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
Jul 4, 2019
Primary completion
Dec 6, 2019
Completion
Dec 6, 2019
Last update
Oct 28, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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