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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: HEC585; Drug: placebo

• Registration Number: NCT04512170
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-13
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-13
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single and Mulltiple doses HEC585（ Part 1, Cohort 1）	placebo	Healthy subjects receive Single and multiple doses of HEC585 or matching placebo
Single and Mulltiple doses HEC585（ Part 1, Cohort 2）	placebo	Healthy subjects receive Single and multiple doses of HEC585 or matching placebo
Single and Mulltiple doses HEC585（ Part 1, Cohort 3）	placebo	Healthy subjects receive Single and multiple doses of HEC585 or matching placebo
Single dose of HEC585 （Part 2，Fed/Fasting）	placebo	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.
two-period study at 400 mg dose group (part 3，Fed)	placebo	Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles.
A single dose HEC585（pilot trial arm）	HEC585	Healthy subjects receive a single dose of HEC585
Single and Mulltiple doses HEC585（ Part 1, Cohort 1）	HEC585	Healthy subjects receive Single and multiple doses of HEC585 or matching placebo
Single and Mulltiple doses HEC585（ Part 1, Cohort 2）	HEC585	Healthy subjects receive Single and multiple doses of HEC585 or matching placebo
Single and Mulltiple doses HEC585（ Part 1, Cohort 3）	HEC585	Healthy subjects receive Single and multiple doses of HEC585 or matching placebo
Single dose of HEC585 （Part 2，Fed/Fasting）	HEC585	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.
two-period study at 400 mg dose group (part 3，Fed)	HEC585	Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 -R	up to 96 hours	the Accumulation Ratio
PK parameters - MRT	up to 96 hours	the Mean Residence Time
Food Effect	up to 96 hours	Effect of Food on PK parameters of HEC585
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 -Vz/F	up to 96 hours	apparent volume of distribution
PK parameters -CL/F	up to 96 hours	the Apparent Clearance

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, China