This study adopts a randomized, double-blind, parallel placebo-controlled dose-escalation design, consisting of two parts: Part 1 includes a single ascending dose (SAD) study plus a food effect (FE) study, and Part 2 is a multiple ascending dose (MAD) study.
Part 1: SAD and FE Studies The SAD and FE studies are conducted concurrently, with a total of 5 dose groups: 2 mg, 5 mg, 10 mg, 20 mg, and 40 mg. A total of 46 healthy adult subjects are planned for enrollment. Except for the 5 mg group, each dose group will include 8 subjects, who will be randomly assigned to receive DC6001 tablets (6 subjects) or DC6001 placebo (2 subjects). The 5 mg group will be combined with the FE study, with 14 planned subjects randomly allocated to DC6001 tablets (12 subjects) or placebo (2 subjects). In the first cycle, a single dose will be administered under fasting conditions. After blood sample collection and safety assessment on Day 9 (D9), the second cycle will be conducted on Day 10 (D10) with administration under high-fat postprandial conditions, followed by blood sample collection and discharge safety examinations. Part 2: MAD Study The MAD study is tentatively designed with 3 dose groups: 2 mg, 5 mg, and 10 mg (to be adjusted based on SAD study results). A total of 30 healthy adult subjects are planned for enrollment, with 10 subjects per dose group randomly assigned to receive DC6001 tablets (8 subjects) or DC6001 placebo (2 subjects). The tentative administration regimen is once-daily fasting administration for 14 consecutive days (to be adjusted based on SAD study results). The SAD and MAD study will proceed sequentially from the lowest dose group. After subjects in a given dose group complete discharge safety examinations, the Safety Review Committee (SRC) will assess whether the dose escalation termination criteria are met. If not, the dose will be escalated to the next group until the highest dose group is completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 6.0
Time frame: Up to 28 days
The maximum plasma concentration of the drug (Cmax)
Time frame: From time zero up to 192 hours post-dose
The time at which the peak plasma concentration is reached (Tmax)
Time frame: From time zero up to 192 hours post-dose
The area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Time frame: From time zero up to 192 hours post-dose
The area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Time Frame: From time zero up to 192 hours post-dose
The time required for the plasma concentration to decrease by half (T1/2)
Time frame: From time zero up to 192 hours post-dose
Change from baseline in plasma RBP4 levels
Time frame: From time zero up to 336 hours post-dose
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