Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525168
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Safety Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Clinical Study of the Safety Tolerability Food Effect and Pharmacokinetics of DA414 Granules After Single and Multiple Administration in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DA414
Brief Summary:
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
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None