the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

NCT04623814 | Completed Phase 1

• 1 other identifier: HEC113995-P-04/CRC-C2006
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Adverse event

  To assess the safety and tolerability of therapy

  up to 34 days

Secondary Outcomes (10)

• Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )

  up to 120 hours

• Maximum Plasma Concentration （ Cmax）

  up to 120 hours

• Time to peak（tmax）

  up to 120 hours

• Apparent terminal elimination half-life（t½）

  up to 120 hours

• Apparent volume of distribution（Vz/F）

  up to 120 hours

Study Arms (5)

Food effect

EXPERIMENTAL

HEC113995 20mg will be administered fasted, with regular meal or with high-fat meal for once.

Other: Food

Multiple Ascending Doses-HEC113995 10mg

EXPERIMENTAL

HEC113995 10mg will be administered fasted for 10 days

Drug: HEC113995

Multiple Ascending Doses-HEC113995 20mg

EXPERIMENTAL

HEC113995 20mg will be administered with food for 10 days

Drug: HEC113995

Multiple Ascending Doses-HEC113995 40mg

EXPERIMENTAL

HEC113995 40mg will be administered with food for 10 days

Drug: HEC113995

Multiple Ascending Doses-placebo

PLACEBO COMPARATOR

Placebo arms will be administered fasted or with food for 10 days

Drug: placebo

Interventions

Food OTHER

HEC113995 20mg will be taken orally fasted or with food

Food effect

HEC113995 DRUG

HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days

Multiple Ascending Doses-HEC113995 10mg; Multiple Ascending Doses-HEC113995 20mg; Multiple Ascending Doses-HEC113995 40mg

placebo DRUG

The placebo will be administered fasted or with food for 10 days.

Multiple Ascending Doses-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 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) ,or anaphylaxis physique.
• \. 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.
• \. 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.
• \. 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.
• \. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
• \. 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

Interventions

Food

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 10, 2020
• Study Start: March 30, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)