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Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects

Study Purpose

The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Without Plann 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 ≥19 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 suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation. 3. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s), anaphylaxis physique. 4. 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. 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, or inability to refrain from smoking during the course of the study. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04512170
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sunshine Lake Pharma Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: A single dose HEC585(pilot trial arm)

Healthy subjects receive a single dose of HEC585

Experimental: Single and Mulltiple doses HEC585( Part 1, Cohort 1)

Healthy subjects receive Single and multiple doses of HEC585 or matching placebo

Experimental: Single and Mulltiple doses HEC585( Part 1, Cohort 2)

Healthy subjects receive Single and multiple doses of HEC585 or matching placebo

Experimental: Single and Mulltiple doses HEC585( Part 1, Cohort 3)

Healthy subjects receive Single and multiple doses of HEC585 or matching placebo

Experimental: Single dose of HEC585 (Part 2,Fed/Fasting)

Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.

Experimental: two-period study at 400 mg dose group (part 3,Fed)

Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles.

Interventions

Drug: - HEC585

single or Mulltiple doses up to 10 days

Drug: - placebo

single or Mulltiple doses up to 10 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai Xuhui Central Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Xuhui Central Hospital

Shanghai, ,

Site Contact

YanMei Liu, MS

ymliu@shxh-centerlab.com

021-54030254