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

NCT07275775 | Completed Phase 1

• 1 other identifier: D2570-102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (77)

• 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 Outcomes (4)

• Result of safety endpoint

  During the procedure

• Result of safety endpoint

  During the procedure

• Result of PD endpoint

  Day1 of group SAD

• Result of PD endpoint

  Day1 and Day7 of group MAD

Study Arms (6)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Drug: D-2570; Drug: Placebo

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

EXPERIMENTAL

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

Drug: D-2570; Drug: Placebo

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

EXPERIMENTAL

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

Drug: D-2570; Drug: Placebo

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

EXPERIMENTAL

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

Drug: D-2570

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

EXPERIMENTAL

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

Placebo 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; Compare the effects of D-2570 with Placebo on the QT/QTc interval for assess; Compare the effects of multiple doses D-2570 with Placebo on serum IL-17A; Compare the safety and tolerability of D-2570 tablets with Placebo for evaluation

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.

Assess the effects of regular and high-fat on the pharmacokinetics of D-2570 tablets; Characterize the pharmacokinetics of single, multiple doses of D-2570 tablets and Placebo; Compare the effects of D-2570 with Placebo on the QT/QTc interval for assess; Compare the effects of multiple doses D-2570 with Placebo on serum IL-17A; Compare the safety and tolerability of D-2570 tablets with Placebo for evaluation; Evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Shuguang Hospital

Shanghai, Shanghai Municipality, 200021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 10, 2025
• Study Start: August 13, 2024
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)