Healthy
Conditions
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.
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.
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of blood biochemistry test | During the procedure | Sodium |
| Assessment of coagulation parameters test | During the procedure | Thrombin time |
| Result of PK endpoints | Day1 to Day7 of group SAD | Tmax |
| Assessment of urinalysis test | During the procedure | pH measurement |
| Assessment of hematology test | During the procedure | Red blood cell count |
| Incidence of adverse events | During the procedure | Incidence of adverse events |
| Result of vital signs | During the procedure | Test of resting blood pressure. |
| Result of physical examination | During the procedure | Test of height (meters） |
| Result of electrocardiogram | During the procedure | Test of beats per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Result of safety endpoint | During the procedure | Test of QT Interva. |
| Result of PD endpoint | Day1 of group SAD | Test of serum IL-17A. |
Countries
China
Outcome results
None listed