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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label，Crossover, Food Effect Study of HEC585 in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512170
• Other study ID #: HEC585-P-02 / CRC-C1938
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2020
• Est. completion date: August 23, 2021

Study information

• Verified date: March 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• HEC585
single or Mulltiple doses up to 10 days
• placebo
single or Mulltiple doses up to 10 days

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses	To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD	up to 18 days
Secondary	PK parameters - AUC0-8	area under the concentration versus time curve (AUC) from time zero to infinity	up to 96 hours
Secondary	PK parameters - Cmax	Geometric Mean of Maximum Observed Plasma Concentration of HEC585	up to 96 hours
Secondary	PK parameters -tmax	maximum observed plasma concentration	up to 96 hours
Secondary	PK parameters -t½	apparent terminal elimination half-life	up to 96 hours
Secondary	PK parameters -Vz/F	apparent volume of distribution	up to 96 hours
Secondary	PK parameters - MRT	the Mean Residence Time	up to 96 hours
Secondary	PK parameters -CL/F	the Apparent Clearance	up to 96 hours
Secondary	PK parameters -R	the Accumulation Ratio	up to 96 hours
Secondary	Food Effect	Effect of Food on PK parameters of HEC585	up to 96 hours