The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.
Acute ischemic stroke is the most common type of stroke, characterized by high incidence, prevalence, recurrence, disability, and mortality rates, posing a serious threat to public health. However, the current treatment measures are limited and often ineffective. According to existing preclinical data, DA414 has demonstrated significant development potential in both in vitro and in vivo pharmacodynamic studies across multiple batches and models. Based on the data-driven insights, the sponsor will conduct single ascending dose (SAD) studies, multiple ascending dose (MAD) studies, and food effect studies of DA414 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
DA414 Granules single ascending doses. DA414 will be orally administrated at single ascending doses of 12.5 mg, 25mg, 50 mg, 100mg and 200 mg.
DA414 placebo single ascending doses. DA414 placebowill be orally administrated at single ascending doses of 25mg, 50 mg, 100mg and 200 mg.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hubei.China, China
RECRUITINGsafety and tolerability
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
Time frame: Through study completion, an average of 28 days.
Cmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
AUC0-t
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Tmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
T1/2
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
CL/F
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Vz/F
Plasma samples were collected at different points for pharmacokinetic analysis.
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Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
AUC0-∞
Plasma samples were collected at different points for pharmacokinetic analysis.
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.