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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple doses SC1011 300mg(A1) | Experimental | Drug: SC1011 tablet, SC1011-matching placebo tablet; Treatment: Food intake prior to dosing |
|
| Multiple doses SC1011 400mg(A2) | Experimental | Drug: SC1011 tablet; Treatment: Food intake prior to dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC1011 | Drug | SC1011 tablet |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200020 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | 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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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Placebo tablet | Drug | SC1011-matching placebo tablet |
|
|
| D008722 | Methods |