Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.

Detailed Description
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This is a single-center, open label study to evaluate the safety，tolerability and pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2 groups. Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1, twice daily on days 2-6 and once within half an hour after breakfast on day 7 . Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days, with dosing consisting of one dose within half an hour after breakfast on day 1, twice daily on days 2-6, and once within half an hour after breakfast on day 7.

Official Title
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A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: SC1011
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator. Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in. Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant. Participants who participated in other clinical trials within 3 months prior to administration. Blood donation or blood loss exceeding 400 mL within 2 months prior to administration. Participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple doses SC1011 300mg（A1）<br>Drug: SC1011 tablet, SC1011-matching placebo tablet; Treatment: Food intake prior to dosing | Drug: SC1011<br>* SC1011 tablet<br>* Other names: experimental drug group;Drug: Placebo tablet<br>* SC1011-matching placebo tablet<br>* Other names: Control Group;|
| Experimental: Multiple doses SC1011 400mg（A2）<br>Drug: SC1011 tablet; Treatment: Food intake prior to dosing | Drug: SC1011<br>* SC1011 tablet<br>* Other names: experimental drug group;Drug: Placebo tablet<br>* SC1011-matching placebo tablet<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events and serious adverse events related drug. | Adverse events are coded according to the ICH Medical Dictionary of Regulatory Activities (MedDRA 24.0 or above). ADR: Adverse events that are definitely related, probably related, or undetermined in relation to the investigational drug. | From baseline to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean of Maximum Observed Plasma Concentration of SC1011 | Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011 | From baseline to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases