Shuguang Hospital
Shanghai, Shanghai Municipality, 200021, China
NCT Number: NCT07275775
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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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200021, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
A placebo refers to a tablet that has no therapeutic effect on medication.
Time frame: During the procedure
Incidence of adverse events
Time frame: During the procedure
Test of resting blood pressure.
Time frame: During the procedure
Test of resting heart pulse.
Time frame: During the procedure
Test of respiratory rate.
Time frame: During the procedure
Test of body temperature.
Time frame: During the procedure
Test of height (meters)
Time frame: During the procedure
Test of weight (kilograms)
Time frame: During the procedure
Test of beats per minute
Time frame: During the procedure
Test of RR Interva
Time frame: During the procedure
Test of PR Interva
Time frame: During the procedure
Test of QRS Interva
Time frame: During the procedure
Test of QT Interva
Time frame: During the procedure
Test of QTcF msec
Time frame: Day1 to Day7 of group SAD
Tmax
Time frame: Day1 to Day13 of group MAD
Tmax
Time frame: Day1 to Day7 for every cycle of group FE
Tmax
Time frame: Day1 to Day7 of group SAD
Cmax
Time frame: Day1 to Day13 of group MAD
Cmax
Time frame: Day1 to Day7 for every cycle of group FE
Cmax
Time frame: Day1 to Day7 of group SAD
t1/2
Time frame: Day1 to Day13 of group MAD
t1/2
Time frame: Day1 to Day7 for every cycle of group FE
t1/2
Time frame: Day1 to Day7 of group SAD
MRT
Time frame: Day1 to Day13 of group MAD
MRT
Time frame: Day1 to Day7 for every cycle of group FE
MRT
Time frame: Day1 to Day7 of group SAD
AUC0-∞
Time frame: Day1 to Day13 of group MAD
AUC0-∞
Time frame: Day1 to Day7 for every cycle of group FE
AUC0-∞
Time frame: Day1 to Day7 of group SAD
AUC0-t
Time frame: Day1 to Day13 of group MAD
AUC0-t
Time frame: Day1 to Day7 for every cycle of group FE
AUC0-t
Time frame: Day1 to Day7 of group SAD
CL/F
Time frame: Day1 to Day13 of group MAD
CL/F
Time frame: Day1 to Day7 for every cycle of group FE
CL/F
Time frame: Day1 to Day7 of group SAD
Vz/F
Time frame: Day1 to Day13 of group MAD
Vz/F
Time frame: Day1 to Day7 for every cycle of group FE
Vz/F
Time frame: During the procedure
Red blood cell count
Time frame: During the procedure
Hemoglobin measurement
Time frame: During the procedure
Hematocrit measurement
Time frame: During the procedure
Platelet count
Time frame: During the procedure
White blood cell count
Time frame: During the procedure
Lymphocyte count
Time frame: During the procedure
Neutrophil count
Time frame: During the procedure
Monocyte count
Time frame: During the procedure
Eosinophil count
Time frame: During the procedure
Basophil count
Time frame: During the procedure
pH measurement
Time frame: During the procedure
Protein detection
Time frame: During the procedure
White blood cells count
Time frame: During the procedure
Red blood cells count
Time frame: During the procedure
Glucose measurement
Time frame: During the procedure
Specific gravity measurement
Time frame: During the procedure
Thrombin time
Time frame: During the procedure
Partial thromboplastin time
Time frame: During the procedure
International normalized ratio
Time frame: During the procedure
Fibrinogen
Time frame: During the procedure
Sodium
Time frame: During the procedure
Potassium
Time frame: During the procedure
Calcium
Time frame: During the procedure
Chlorine
Time frame: During the procedure
Total protein
Time frame: During the procedure
Albumin
Time frame: During the procedure
Alkaline phosphatase
Time frame: During the procedure
Alanine aminotransferase
Time frame: During the procedure
Aspartate aminotransferase
Time frame: During the procedure
Direct bilirubin
Time frame: During the procedure
Indirect bilirubin
Time frame: During the procedure
Total bilirubin
Time frame: During the procedure
Gamma glutamyl transferase
Time frame: During the procedure
Uric acid
Time frame: During the procedure
Creatinine
Time frame: During the procedure
Creatine kinase
Time frame: During the procedure
Urea
Time frame: During the procedure
Glucose
Time frame: During the procedure
Total cholesterol
Time frame: During the procedure
Triglycerides
Time frame: During the procedure
Test of QT Interva.
Time frame: During the procedure
Test of QTc Interva.
Time frame: Day1 of group SAD
Test of serum IL-17A.
Time frame: Day1 and Day7 of group MAD
Test of serum IL-17A.
InventisBio Co., Ltd
Industry
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-2570 Tablets in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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