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

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04512170

Collaborator

(none)

Enrollment

Location

Arms

13.3

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: HEC585 Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Ascending Single and Multiple Dose Study is Double-blind design; Food Effect Study is open-label design.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 13, 2020

Actual Primary Completion Date :

Aug 23, 2021

Actual Study Completion Date :

Aug 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [up to 18 days]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects who are willing and are able to provide a written informed consent to participate in the study.
Without Plann 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 ≥19 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).

Exclusion Criteria:

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 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.
Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.
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.
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, or inability to refrain from smoking during the course of the study.
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.
Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Xuhui Central Hospital	Shanghai		China

Sponsors and Collaborators

Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04512170

Other Study ID Numbers:

HEC585-P-02 / CRC-C1938

First Posted:

Aug 13, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Study Results

No Results Posted as of Mar 15, 2022