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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- InventisBio Co., Ltd
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
- •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.
Arms & Interventions
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.
Intervention: Placebo (Drug)
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.
Intervention: D-2570 (Drug)
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.
Intervention: Placebo (Drug)
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.
Intervention: D-2570 (Drug)
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.
Intervention: Placebo (Drug)
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.
Intervention: D-2570 (Drug)
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.
Intervention: Placebo (Drug)
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.
Intervention: D-2570 (Drug)
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.
Intervention: D-2570 (Drug)
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)
Intervention: D-2570 (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: During the procedure
Incidence of adverse events
Result of vital signs
Time Frame: During the procedure
Test of body temperature.
Result of physical examination
Time Frame: During the procedure
Test of weight (kilograms)
Result of electrocardiogram
Time Frame: During the procedure
Test of QTcF msec
Result of PK endpoints
Time Frame: Day1 to Day7 for every cycle of group FE
Vz/F
Assessment of hematology test
Time Frame: During the procedure
Basophil count
Assessment of urinalysis test
Time Frame: During the procedure
Specific gravity measurement
Assessment of coagulation parameters test
Time Frame: During the procedure
Fibrinogen
Assessment of blood biochemistry test
Time Frame: During the procedure
Triglycerides
Secondary Outcomes
- Result of safety endpoint(During the procedure)
- Result of PD endpoint(Day1 and Day7 of group MAD)