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

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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: HEC585; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A single dose HEC585（pilot trial arm）; Healthy subjects receive a single dose of HEC585	Drug: HEC585; single or Mulltiple doses up to 10 days
Experimental: Single and Mulltiple doses HEC585（ Part 1, Cohort 1）; Healthy subjects receive Single and multiple doses of HEC585 or matching placebo	Drug: HEC585; single or Mulltiple doses up to 10 days; Drug: placebo; single or Mulltiple doses up to 10 days
Experimental: Single and Mulltiple doses HEC585（ Part 1, Cohort 2）; Healthy subjects receive Single and multiple doses of HEC585 or matching placebo	Drug: HEC585; single or Mulltiple doses up to 10 days; Drug: placebo; single or Mulltiple doses up to 10 days
Experimental: Single and Mulltiple doses HEC585（ Part 1, Cohort 3）; Healthy subjects receive Single and multiple doses of HEC585 or matching placebo	Drug: HEC585; single or Mulltiple doses up to 10 days; Drug: placebo; single or Mulltiple doses up to 10 days
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.	Drug: HEC585; single or Mulltiple doses up to 10 days; Drug: placebo; single or Mulltiple doses up to 10 days
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.	Drug: HEC585; single or Mulltiple doses up to 10 days; Drug: placebo; single or Mulltiple doses up to 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters - AUC0-∞	area under the concentration versus time curve (AUC) from time zero to infinity	up to 96 hours
PK parameters - Cmax	Geometric Mean of Maximum Observed Plasma Concentration of HEC585	up to 96 hours
PK parameters -tmax	maximum observed plasma concentration	up to 96 hours
PK parameters -t½	apparent terminal elimination half-life	up to 96 hours
PK parameters -Vz/F	apparent volume of distribution	up to 96 hours
PK parameters - MRT	the Mean Residence Time	up to 96 hours
PK parameters -CL/F	the Apparent Clearance	up to 96 hours
PK parameters -R	the Accumulation Ratio	up to 96 hours
Food Effect	Effect of Food on PK parameters of HEC585	up to 96 hours

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: HEC585-P-02 / CRC-C1938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No