The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects. The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Participants receive 40mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 40mg of ND-003.
Participants receive 80mg ND-003 tablets once.
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Adverse Events (AE)
Number and type of participants with treatment-related adverse events
Time frame: through study completion, an average of 1 month
maximum concentration (Cmax)
The drug maximum concentration reaches when the absorption rate is equal to the elimination rate at a single dose.
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Time to maximum concentration (Tmax)
Time required to reach peak drug concentration after a single administration.
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Elimination Half-life (t1/2)
Elimination Half-life (t1/2) refers to the time required to eliminate 50% of the drug from the body.
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Clearance (CLz/F)
Clearance (CLz/F) describes how the body effectively eliminate drugs from the systemic circulation, typically defined as the volume of drug-containing plasma eliminated from the body per unit time.
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC from time 0 to last time of quantifiable concentration (AUC0-t)
Area under the plasma concentration-time curve from the initial administration to the last measurable concentration point.
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
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Participants receive placebo tablet matching to receive 80mg of ND-003.
Participants receive 160mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 160mg of ND-003.
Participants receive 240mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 240mg of ND-003.
Participants receive 300mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 300mg of ND-003.
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3
Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.
Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.