the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Other: Food; Drug: HEC113995; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04623814

HEC113995-P-04/CRC-C2006

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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58 participants in 5 patient groups, including a placebo group

Food effect

Experimental group

Description:

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

Treatment:

Other: Food

Multiple Ascending Doses-HEC113995 10mg

Experimental group

Description:

HEC113995 10mg will be administered fasted for 10 days

Treatment:

Drug: HEC113995

Multiple Ascending Doses-HEC113995 20mg

Experimental group

Description:

HEC113995 20mg will be administered with food for 10 days

Treatment:

Drug: HEC113995

Multiple Ascending Doses-HEC113995 40mg

Experimental group

Description:

HEC113995 40mg will be administered with food for 10 days

Treatment:

Drug: HEC113995

Multiple Ascending Doses-placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo