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

InventisBio

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: D-2570; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07275775

D2570-102

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 6 patient groups

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

Experimental group

Description:

To assess the safety and tolerability of single, multiple doses and food effect trial of D-2570 tablets and Placebo in healthy subjects.

Treatment:

Drug: Placebo

Drug: D-2570

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: D-2570

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: D-2570

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: D-2570

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

Experimental group

Description:

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

Treatment:

Drug: D-2570

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

Experimental group

Description:

To evaluate the relative bioavailability among health benefits of D-2570 tablets (9 mg specification) and D-2570 tablets (3 mg specification)

Treatment:

Drug: D-2570