CClinicalTrials.gg
Sign In
CompletedNCT07275775Updated Dec 10, 2025

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

A Phase 1 interventional study of D-2570 and Placebo in Healthy, sponsored by InventisBio Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by InventisBio Co., Ltd · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

InventisBio Co., Ltd is the lead sponsor of 32 studies on the registry; 10 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Compare the safety and tolerability of D-2570 tablets with Placebo for evaluation

    To assess the safety and tolerability of single, multiple doses and food effect trial of D-2570 tablets and Placebo in healthy subjects.

    Drug: D-2570 · Drug: Placebo

  • Experimental
    Characterize the pharmacokinetics of single, multiple doses of D-2570 tablets and Placebo

    To characterize the pharmacokinetics (PK) of single, multiple doses of D-2570 tablets and Placebo in healthy subjects.

    Drug: D-2570 · Drug: Placebo

  • Experimental
    Compare the effects of D-2570 with Placebo on the QT/QTc interval for assess

    To assess the effects of D-2570 and Placebo on the QT/QTc interval in healthy subjects.

    Drug: D-2570 · Drug: Placebo

  • Experimental
    Compare the effects of multiple doses D-2570 with Placebo on serum IL-17A

    To assess the effects of multiple doses D-2570 and Placebo on serum IL-17A in healthy subjects.

    Drug: D-2570 · Drug: Placebo

  • Experimental
    Assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tablets

    To assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tablets.

    Drug: D-2570

  • Experimental
    Evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification)

    To evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification) and D-2570 tablets (3 mg specification)

    Drug: D-2570

Interventions

  • DrugD-2570

    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.

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

    Incidence of adverse events

    Time frame: During the procedure

  2. Result of vital signs

    Test of resting blood pressure.

    Time frame: During the procedure

  3. Result of vital signs

    Test of resting heart pulse.

    Time frame: During the procedure

  4. Result of vital signs

    Test of respiratory rate.

    Time frame: During the procedure

  5. Result of vital signs

    Test of body temperature.

    Time frame: During the procedure

  6. Result of physical examination

    Test of height (meters）

    Time frame: During the procedure

  7. Result of physical examination

    Test of weight (kilograms)

    Time frame: During the procedure

  8. Result of electrocardiogram

    Test of beats per minute

    Time frame: During the procedure

  9. Result of electrocardiogram

    Test of RR Interva

    Time frame: During the procedure

  10. Result of electrocardiogram

    Test of PR Interva

    Time frame: During the procedure

  11. Result of electrocardiogram

    Test of QRS Interva

    Time frame: During the procedure

  12. Result of electrocardiogram

    Test of QT Interva

    Time frame: During the procedure

  13. Result of electrocardiogram

    Test of QTcF msec

    Time frame: During the procedure

  14. Result of PK endpoints

    Tmax

    Time frame: Day1 to Day7 of group SAD

  15. Result of PK endpoints

    Tmax

    Time frame: Day1 to Day13 of group MAD

  16. Result of PK endpoints

    Tmax

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

  17. Result of PK endpoints

    Cmax

    Time frame: Day1 to Day7 of group SAD

  18. Result of PK endpoints

    Cmax

    Time frame: Day1 to Day13 of group MAD

  19. Result of PK endpoints

    Cmax

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

  20. Result of PK endpoints

    t1/2

    Time frame: Day1 to Day7 of group SAD

  21. Result of PK endpoints

    t1/2

    Time frame: Day1 to Day13 of group MAD

  22. Result of PK endpoints

    t1/2

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

  23. Result of PK endpoints

    MRT

    Time frame: Day1 to Day7 of group SAD

  24. Result of PK endpoints

    MRT

    Time frame: Day1 to Day13 of group MAD

  25. Result of PK endpoints

    MRT

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

  26. Result of PK endpoints

    AUC0-∞

    Time frame: Day1 to Day7 of group SAD

  27. Result of PK endpoints

    AUC0-∞

    Time frame: Day1 to Day13 of group MAD

  28. Result of PK endpoints

    AUC0-∞

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

  29. Result of PK endpoints

    AUC0-t

    Time frame: Day1 to Day7 of group SAD

  30. Result of PK endpoints

    AUC0-t

    Time frame: Day1 to Day13 of group MAD

  31. Result of PK endpoints

    AUC0-t

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

  32. Result of PK endpoints

    CL/F

    Time frame: Day1 to Day7 of group SAD

  33. Result of PK endpoints

    CL/F

    Time frame: Day1 to Day13 of group MAD

  34. Result of PK endpoints

    CL/F

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

  35. Result of PK endpoints

    Vz/F

    Time frame: Day1 to Day7 of group SAD

  36. Result of PK endpoints

    Vz/F

    Time frame: Day1 to Day13 of group MAD

  37. Result of PK endpoints

    Vz/F

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

  38. Assessment of hematology test

    Red blood cell count

    Time frame: During the procedure

  39. Assessment of hematology test

    Hemoglobin measurement

    Time frame: During the procedure

  40. Assessment of hematology test

    Hematocrit measurement

    Time frame: During the procedure

  41. Assessment of hematology test

    Platelet count

    Time frame: During the procedure

  42. Assessment of hematology test

    White blood cell count

    Time frame: During the procedure

  43. Assessment of hematology test

    Lymphocyte count

    Time frame: During the procedure

  44. Assessment of hematology test

    Neutrophil count

    Time frame: During the procedure

  45. Assessment of hematology test

    Monocyte count

    Time frame: During the procedure

  46. Assessment of hematology test

    Eosinophil count

    Time frame: During the procedure

  47. Assessment of hematology test

    Basophil count

    Time frame: During the procedure

  48. Assessment of urinalysis test

    pH measurement

    Time frame: During the procedure

  49. Assessment of urinalysis test

    Protein detection

    Time frame: During the procedure

  50. Assessment of urinalysis test

    White blood cells count

    Time frame: During the procedure

  51. Assessment of urinalysis test

    Red blood cells count

    Time frame: During the procedure

  52. Assessment of urinalysis test

    Glucose measurement

    Time frame: During the procedure

  53. Assessment of urinalysis test

    Specific gravity measurement

    Time frame: During the procedure

  54. Assessment of coagulation parameters test

    Thrombin time

    Time frame: During the procedure

  55. Assessment of coagulation parameters test

    Partial thromboplastin time

    Time frame: During the procedure

  56. Assessment of coagulation parameters test

    International normalized ratio

    Time frame: During the procedure

  57. Assessment of coagulation parameters test

    Fibrinogen

    Time frame: During the procedure

  58. Assessment of blood biochemistry test

    Sodium

    Time frame: During the procedure

  59. Assessment of blood biochemistry test

    Potassium

    Time frame: During the procedure

  60. Assessment of blood biochemistry test

    Calcium

    Time frame: During the procedure

  61. Assessment of blood biochemistry test

    Chlorine

    Time frame: During the procedure

  62. Assessment of blood biochemistry test

    Total protein

    Time frame: During the procedure

  63. Assessment of blood biochemistry test

    Albumin

    Time frame: During the procedure

  64. Assessment of blood biochemistry test

    Alkaline phosphatase

    Time frame: During the procedure

  65. Assessment of blood biochemistry test

    Alanine aminotransferase

    Time frame: During the procedure

  66. Assessment of blood biochemistry test

    Aspartate aminotransferase

    Time frame: During the procedure

  67. Assessment of blood biochemistry test

    Direct bilirubin

    Time frame: During the procedure

  68. Assessment of blood biochemistry test

    Indirect bilirubin

    Time frame: During the procedure

  69. Assessment of blood biochemistry test

    Total bilirubin

    Time frame: During the procedure

  70. Assessment of blood biochemistry test

    Gamma glutamyl transferase

    Time frame: During the procedure

  71. Assessment of blood biochemistry test

    Uric acid

    Time frame: During the procedure

  72. Assessment of blood biochemistry test

    Creatinine

    Time frame: During the procedure

  73. Assessment of blood biochemistry test

    Creatine kinase

    Time frame: During the procedure

  74. Assessment of blood biochemistry test

    Urea

    Time frame: During the procedure

  75. Assessment of blood biochemistry test

    Glucose

    Time frame: During the procedure

  76. Assessment of blood biochemistry test

    Total cholesterol

    Time frame: During the procedure

  77. Assessment of blood biochemistry test

    Triglycerides

    Time frame: During the procedure

Secondary outcomes

  1. Result of safety endpoint

    Test of QT Interva.

    Time frame: During the procedure

  2. Result of safety endpoint

    Test of QTc Interva.

    Time frame: During the procedure

  3. Result of PD endpoint

    Test of serum IL-17A.

    Time frame: Day1 of group SAD

  4. Result of PD endpoint

    Test of serum IL-17A.

    Time frame: Day1 and Day7 of group MAD

07

Study locations

1 site
  • Shuguang Hospital
    Shanghai, Shanghai Municipality 200021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07275775
Lead sponsor
InventisBio Co., Ltd
Responsible party
Sponsor
First posted
Dec 10, 2025
Start date
Aug 13, 2024
Primary completion
Jun 23, 2025
Completion
Jun 23, 2025
Last update
Dec 10, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

InventisBio Co., Ltd

Start the discussion