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The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer are:
Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy subjects.Food effect in healthy subjects.Participants will complete the study including screening period, dosing period, and observation period. Researchers 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.
This is a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Part B will comprise a multiple-dose, sequential-group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single dose SC1011 50mg(A1) | Experimental | Drug: SC1011 tablet Treatment: No food prior to dosing |
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| A single dose SC1011 150mg(A2) | Placebo Comparator | Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing |
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| A single dose SC1011 150 mg(A3) | Experimental | Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing |
|
| A single dose SC1011 300mg(A4) | Experimental | Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC1011 | Drug | Each subject in the SAD groups participated in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours post dose). |
| 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. | Evaluations will be conducted for up to 7 days after first administration |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Maximum Observed Plasma Concentration of SC1011 | Peak concentration. It was directly obtained from the measured data of blood concentration and time. | Evaluations will be conducted for up to 7 days after first administration |
| Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guang Zhou University of Chinese Medicine | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D054988 | Idiopathic Interstitial Pneumonias |
| D011658 | Pulmonary Fibrosis |
| D054990 | Idiopathic Pulmonary Fibrosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel assignment
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The area under the curve extrapolated from zero to infinity. AUC0-∞=AUC0-t+Ct/λz(Ct is the last determinable blood concentration, λz is elimination rate constant). |
| Evaluations will be conducted for up to 7 days after first administration |