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Completed

NCT Number: NCT07275775

Single and Multiple Dose and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-2570 Tablets in Healthy Subjects

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shuguang Hospital

Shanghai, Shanghai Municipality, 200021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol;
  • Subjects who can take effective contraceptive measures from the start of screening to 6 months after the last dose of the IMP;
  • Male and female subjects aged 18 to 45 years (inclusive);
  • Male weight ≥ 50 kg, female weight ≥ 45 kg. Body mass index (BMI) = body weight (kg) / height2 (m2). BMI ranging from 19 to 26 kg/m2 (inclusive);
  • Subjects without medical history of clinically significant respiratory, circulatory, digestive, urinary, hematological, endocrine, nervous system diseases, metabolic abnormalities or infections, etc.

Exclusion criteria

  • More than 5 cigarettes per day on average within 3 months before screening;
  • Subjects with a clinically significant history of drug allergy or specific allergic diseases (asthma, urticaria) or known allergy to the IMP or its excipients;
  • History of alcohol abuse (consuming an average of 14 units of alcohol per week within 3 months prior to screening: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
  • Subjects with a history of substance or drug abuse or a positive urine drug screening;
  • Blood donation or massive blood loss (>450 mL) within 3 months before screening.

Treatment and study plan

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.

Placebo

Drug

A placebo refers to a tablet that has no therapeutic effect on medication.

Primary outcomes

  1. Incidence of adverse events

    Time frame: During the procedure

    Incidence of adverse events

  2. Result of vital signs

    Time frame: During the procedure

    Test of resting blood pressure.

  3. Result of vital signs

    Time frame: During the procedure

    Test of resting heart pulse.

  4. Result of vital signs

    Time frame: During the procedure

    Test of respiratory rate.

  5. Result of vital signs

    Time frame: During the procedure

    Test of body temperature.

  6. Result of physical examination

    Time frame: During the procedure

    Test of height (meters)

  7. Result of physical examination

    Time frame: During the procedure

    Test of weight (kilograms)

  8. Result of electrocardiogram

    Time frame: During the procedure

    Test of beats per minute

  9. Result of electrocardiogram

    Time frame: During the procedure

    Test of RR Interva

  10. Result of electrocardiogram

    Time frame: During the procedure

    Test of PR Interva

  11. Result of electrocardiogram

    Time frame: During the procedure

    Test of QRS Interva

  12. Result of electrocardiogram

    Time frame: During the procedure

    Test of QT Interva

  13. Result of electrocardiogram

    Time frame: During the procedure

    Test of QTcF msec

  14. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    Tmax

  15. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    Tmax

  16. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    Tmax

  17. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    Cmax

  18. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    Cmax

  19. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    Cmax

  20. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    t1/2

  21. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    t1/2

  22. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    t1/2

  23. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    MRT

  24. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    MRT

  25. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    MRT

  26. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    AUC0-∞

  27. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    AUC0-∞

  28. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    AUC0-∞

  29. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    AUC0-t

  30. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    AUC0-t

  31. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    AUC0-t

  32. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    CL/F

  33. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    CL/F

  34. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    CL/F

  35. Result of PK endpoints

    Time frame: Day1 to Day7 of group SAD

    Vz/F

  36. Result of PK endpoints

    Time frame: Day1 to Day13 of group MAD

    Vz/F

  37. Result of PK endpoints

    Time frame: Day1 to Day7 for every cycle of group FE

    Vz/F

  38. Assessment of hematology test

    Time frame: During the procedure

    Red blood cell count

  39. Assessment of hematology test

    Time frame: During the procedure

    Hemoglobin measurement

  40. Assessment of hematology test

    Time frame: During the procedure

    Hematocrit measurement

  41. Assessment of hematology test

    Time frame: During the procedure

    Platelet count

  42. Assessment of hematology test

    Time frame: During the procedure

    White blood cell count

  43. Assessment of hematology test

    Time frame: During the procedure

    Lymphocyte count

  44. Assessment of hematology test

    Time frame: During the procedure

    Neutrophil count

  45. Assessment of hematology test

    Time frame: During the procedure

    Monocyte count

  46. Assessment of hematology test

    Time frame: During the procedure

    Eosinophil count

  47. Assessment of hematology test

    Time frame: During the procedure

    Basophil count

  48. Assessment of urinalysis test

    Time frame: During the procedure

    pH measurement

  49. Assessment of urinalysis test

    Time frame: During the procedure

    Protein detection

  50. Assessment of urinalysis test

    Time frame: During the procedure

    White blood cells count

  51. Assessment of urinalysis test

    Time frame: During the procedure

    Red blood cells count

  52. Assessment of urinalysis test

    Time frame: During the procedure

    Glucose measurement

  53. Assessment of urinalysis test

    Time frame: During the procedure

    Specific gravity measurement

  54. Assessment of coagulation parameters test

    Time frame: During the procedure

    Thrombin time

  55. Assessment of coagulation parameters test

    Time frame: During the procedure

    Partial thromboplastin time

  56. Assessment of coagulation parameters test

    Time frame: During the procedure

    International normalized ratio

  57. Assessment of coagulation parameters test

    Time frame: During the procedure

    Fibrinogen

  58. Assessment of blood biochemistry test

    Time frame: During the procedure

    Sodium

  59. Assessment of blood biochemistry test

    Time frame: During the procedure

    Potassium

  60. Assessment of blood biochemistry test

    Time frame: During the procedure

    Calcium

  61. Assessment of blood biochemistry test

    Time frame: During the procedure

    Chlorine

  62. Assessment of blood biochemistry test

    Time frame: During the procedure

    Total protein

  63. Assessment of blood biochemistry test

    Time frame: During the procedure

    Albumin

  64. Assessment of blood biochemistry test

    Time frame: During the procedure

    Alkaline phosphatase

  65. Assessment of blood biochemistry test

    Time frame: During the procedure

    Alanine aminotransferase

  66. Assessment of blood biochemistry test

    Time frame: During the procedure

    Aspartate aminotransferase

  67. Assessment of blood biochemistry test

    Time frame: During the procedure

    Direct bilirubin

  68. Assessment of blood biochemistry test

    Time frame: During the procedure

    Indirect bilirubin

  69. Assessment of blood biochemistry test

    Time frame: During the procedure

    Total bilirubin

  70. Assessment of blood biochemistry test

    Time frame: During the procedure

    Gamma glutamyl transferase

  71. Assessment of blood biochemistry test

    Time frame: During the procedure

    Uric acid

  72. Assessment of blood biochemistry test

    Time frame: During the procedure

    Creatinine

  73. Assessment of blood biochemistry test

    Time frame: During the procedure

    Creatine kinase

  74. Assessment of blood biochemistry test

    Time frame: During the procedure

    Urea

  75. Assessment of blood biochemistry test

    Time frame: During the procedure

    Glucose

  76. Assessment of blood biochemistry test

    Time frame: During the procedure

    Total cholesterol

  77. Assessment of blood biochemistry test

    Time frame: During the procedure

    Triglycerides

Secondary outcomes

  1. Result of safety endpoint

    Time frame: During the procedure

    Test of QT Interva.

  2. Result of safety endpoint

    Time frame: During the procedure

    Test of QTc Interva.

  3. Result of PD endpoint

    Time frame: Day1 of group SAD

    Test of serum IL-17A.

  4. Result of PD endpoint

    Time frame: Day1 and Day7 of group MAD

    Test of serum IL-17A.

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

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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