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This is a randomized, double-blind, placebo-controlled single and multiple ascending dose and food effect study on PK. Subjects in the SAD and MAD study take the drug under fasting conditions, while those in the food effect (FE) study are required to take the drug under fasting or fed conditions according to the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compare the safety and tolerability of D-2570 tablets with Placebo for evaluation | Experimental | To assess the safety and tolerability of single, multiple doses and food effect trial of D-2570 tablets and Placebo in healthy subjects. |
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| Characterize the pharmacokinetics of single, multiple doses of D-2570 tablets and Placebo | Experimental | To characterize the pharmacokinetics (PK) of single, multiple doses of D-2570 tablets and Placebo in healthy subjects. |
|
| Compare the effects of D-2570 with Placebo on the QT/QTc interval for assess | Experimental | To assess the effects of D-2570 and Placebo on the QT/QTc interval in healthy subjects. |
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| Compare the effects of multiple doses D-2570 with Placebo on serum IL-17A | Experimental | To assess the effects of multiple doses D-2570 and Placebo on serum IL-17A in healthy subjects. |
|
| Assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tablets | Experimental | To assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tablets. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-2570 | Drug | D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain, which can inhibit the release of inflammatory factors and participate in immune regulation. D-2570 is being developed as a potential oral therapeutic drug for patients with psoriasis, ulcerative colitis, SLE, and other conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of adverse events | During the procedure |
| Result of vital signs | Test of resting blood pressure. | During the procedure |
| Result of vital signs | Test of resting heart pulse. | During the procedure |
| Result of vital signs | Test of respiratory rate. | During the procedure |
| Result of vital signs | Test of body temperature. | During the procedure |
| Result of physical examination | Test of height (meters) | During the procedure |
| Result of physical examination | Test of weight (kilograms) | During the procedure |
| Result of electrocardiogram | Test of beats per minute | During the procedure |
| Result of electrocardiogram | Test of RR Interva |
| Measure | Description | Time Frame |
|---|---|---|
| Result of safety endpoint | Test of QT Interva. | During the procedure |
| Result of safety endpoint | Test of QTc Interva. | During the procedure |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuguang Hospital | Shanghai | Shanghai Municipality | 200021 | China |
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|
| Evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification) | Experimental | To evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification) and D-2570 tablets (3 mg specification) |
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| Placebo | Drug | A placebo refers to a tablet that has no therapeutic effect on medication. |
|
| During the procedure |
| Result of electrocardiogram | Test of PR Interva | During the procedure |
| Result of electrocardiogram | Test of QRS Interva | During the procedure |
| Result of electrocardiogram | Test of QT Interva | During the procedure |
| Result of electrocardiogram | Test of QTcF msec | During the procedure |
| Result of PK endpoints | Tmax | Day1 to Day7 of group SAD |
| Result of PK endpoints | Tmax | Day1 to Day13 of group MAD |
| Result of PK endpoints | Tmax | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | Cmax | Day1 to Day7 of group SAD |
| Result of PK endpoints | Cmax | Day1 to Day13 of group MAD |
| Result of PK endpoints | Cmax | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | t1/2 | Day1 to Day7 of group SAD |
| Result of PK endpoints | t1/2 | Day1 to Day13 of group MAD |
| Result of PK endpoints | t1/2 | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | MRT | Day1 to Day7 of group SAD |
| Result of PK endpoints | MRT | Day1 to Day13 of group MAD |
| Result of PK endpoints | MRT | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | AUC0-∞ | Day1 to Day7 of group SAD |
| Result of PK endpoints | AUC0-∞ | Day1 to Day13 of group MAD |
| Result of PK endpoints | AUC0-∞ | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | AUC0-t | Day1 to Day7 of group SAD |
| Result of PK endpoints | AUC0-t | Day1 to Day13 of group MAD |
| Result of PK endpoints | AUC0-t | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | CL/F | Day1 to Day7 of group SAD |
| Result of PK endpoints | CL/F | Day1 to Day13 of group MAD |
| Result of PK endpoints | CL/F | Day1 to Day7 for every cycle of group FE |
| Result of PK endpoints | Vz/F | Day1 to Day7 of group SAD |
| Result of PK endpoints | Vz/F | Day1 to Day13 of group MAD |
| Result of PK endpoints | Vz/F | Day1 to Day7 for every cycle of group FE |
| Assessment of hematology test | Red blood cell count | During the procedure |
| Assessment of hematology test | Hemoglobin measurement | During the procedure |
| Assessment of hematology test | Hematocrit measurement | During the procedure |
| Assessment of hematology test | Platelet count | During the procedure |
| Assessment of hematology test | White blood cell count | During the procedure |
| Assessment of hematology test | Lymphocyte count | During the procedure |
| Assessment of hematology test | Neutrophil count | During the procedure |
| Assessment of hematology test | Monocyte count | During the procedure |
| Assessment of hematology test | Eosinophil count | During the procedure |
| Assessment of hematology test | Basophil count | During the procedure |
| Assessment of urinalysis test | pH measurement | During the procedure |
| Assessment of urinalysis test | Protein detection | During the procedure |
| Assessment of urinalysis test | White blood cells count | During the procedure |
| Assessment of urinalysis test | Red blood cells count | During the procedure |
| Assessment of urinalysis test | Glucose measurement | During the procedure |
| Assessment of urinalysis test | Specific gravity measurement | During the procedure |
| Assessment of coagulation parameters test | Thrombin time | During the procedure |
| Assessment of coagulation parameters test | Partial thromboplastin time | During the procedure |
| Assessment of coagulation parameters test | International normalized ratio | During the procedure |
| Assessment of coagulation parameters test | Fibrinogen | During the procedure |
| Assessment of blood biochemistry test | Sodium | During the procedure |
| Assessment of blood biochemistry test | Potassium | During the procedure |
| Assessment of blood biochemistry test | Calcium | During the procedure |
| Assessment of blood biochemistry test | Chlorine | During the procedure |
| Assessment of blood biochemistry test | Total protein | During the procedure |
| Assessment of blood biochemistry test | Albumin | During the procedure |
| Assessment of blood biochemistry test | Alkaline phosphatase | During the procedure |
| Assessment of blood biochemistry test | Alanine aminotransferase | During the procedure |
| Assessment of blood biochemistry test | Aspartate aminotransferase | During the procedure |
| Assessment of blood biochemistry test | Direct bilirubin | During the procedure |
| Assessment of blood biochemistry test | Indirect bilirubin | During the procedure |
| Assessment of blood biochemistry test | Total bilirubin | During the procedure |
| Assessment of blood biochemistry test | Gamma glutamyl transferase | During the procedure |
| Assessment of blood biochemistry test | Uric acid | During the procedure |
| Assessment of blood biochemistry test | Creatinine | During the procedure |
| Assessment of blood biochemistry test | Creatine kinase | During the procedure |
| Assessment of blood biochemistry test | Urea | During the procedure |
| Assessment of blood biochemistry test | Glucose | During the procedure |
| Assessment of blood biochemistry test | Total cholesterol | During the procedure |
| Assessment of blood biochemistry test | Triglycerides | During the procedure |
| Result of PD endpoint | Test of serum IL-17A. | Day1 of group SAD |
| Result of PD endpoint | Test of serum IL-17A. | Day1 and Day7 of group MAD |