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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: D-2570; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200021
      • ShuGuang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Drug: Placebo; A placebo refers to a tablet that has no therapeutic effect on medication.
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; 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.; Drug: Placebo; A placebo refers to a tablet that has no therapeutic effect on medication.
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; 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.; Drug: Placebo; A placebo refers to a tablet that has no therapeutic effect on medication.
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; 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.; Drug: Placebo; A placebo refers to a tablet that has no therapeutic effect on medication.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Actual): June 23, 2025
• Study Completion (Actual): June 23, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: D2570-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No