NCT06525168

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Chendu DIAO Nine Hong Pharmaceutical Factory · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	DA414 Granules	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.
DRUG	DA414 placebo	DA414 placebo single ascending doses. DA414 placebowill be orally administrated at single ascending doses of 25mg, 50 mg, 100mg and 200 mg.

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2024-07-29
• Last updated: 2024-07-29

Locations

1 site across 1 country: China