To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 6 subjects receive DA-302168S tablets.
SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 2 subjects receive placebo of DA-302168S tablets.
MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 8 subjects receive study DA-302168S tablets.
Gulou Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Safety and Tolerability
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
Time frame: SAD up to Day 5 and MAD up to Day 9.
Peak Plasma Concentration (Cmax)
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Tmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
AUC0-t
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
AUC0-∞
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
t1/2
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
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MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive study placebo of DA-302168S tablets.
CL/F
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Vd/F
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Kel
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.