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

NCT04512170 | Completed Phase 1 FDA Drug

• 1 other identifier: HEC585-P-02 / CRC-C1938
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• PK parameters - AUC0-∞

  up to 96 hours

• PK parameters - Cmax

  up to 96 hours

• PK parameters -tmax

  up to 96 hours

• PK parameters -t½

  up to 96 hours

• PK parameters -Vz/F

  up to 96 hours

Study Arms (6)

A single dose HEC585（pilot trial arm）

EXPERIMENTAL

Healthy subjects receive a single dose of HEC585

Drug: HEC585

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

EXPERIMENTAL

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

Drug: HEC585; Drug: placebo

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

EXPERIMENTAL

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

Drug: HEC585; Drug: placebo

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

EXPERIMENTAL

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

Drug: HEC585; Drug: placebo

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

EXPERIMENTAL

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; Drug: placebo

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

EXPERIMENTAL

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

Drug: HEC585; Drug: placebo

Interventions

HEC585 DRUG

single or Mulltiple doses up to 10 days

A single dose HEC585（pilot trial arm）; Single and Mulltiple doses HEC585（ Part 1, Cohort 1）; Single and Mulltiple doses HEC585（ Part 1, Cohort 2）; Single and Mulltiple doses HEC585（ Part 1, Cohort 3）; Single dose of HEC585 （Part 2，Fed/Fasting）; two-period study at 400 mg dose group (part 3，Fed)

placebo DRUG

single or Mulltiple doses up to 10 days

Single and Mulltiple doses HEC585（ Part 1, Cohort 1）; Single and Mulltiple doses HEC585（ Part 1, Cohort 2）; Single and Mulltiple doses HEC585（ Part 1, Cohort 3）; Single dose of HEC585 （Part 2，Fed/Fasting）; two-period study at 400 mg dose group (part 3，Fed)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ascending Single and Multiple Dose Study is Double-blind design; Food Effect Study is open-label design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: July 13, 2020
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)