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

NCT ID: NCT07275775

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2025-06-23

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: 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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: 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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: 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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: 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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: 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.

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)

Group Type: EXPERIMENTAL

D-2570

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InventisBio Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shuguang Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

D2570-102

Identifier Type: -

Identifier Source: org_study_id