Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-05 @ 6:01 PM
Study NCT ID:
NCT06525168
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
Sponsor:
Chendu DIAO Nine Hong Pharmaceutical Factory
Organization:
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:
False
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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: