초록

1. 국내 비임상 연구자료 확보
- 설치/비설치류 단회투여 및 반복투여 독성 시험 완료
- 유전독성 (복귀돌연변이, 염색체이상, 소핵시험) 완료
- 일반약리독성 시험완료
2. 효력시험자료 확보
3. IND filing을 위한 CMC 자료 확보
-기준 및 시험방법 ,Formulation study, 안정성 시험자료 확보
4. PAD 환자 중 간헐성 파행증에 대한 임상 프로토콜 작성 완료
5. IND 접수 및 승인 완료

Abstract ▼

Ⅰ. The purpose and necessity of the research and development
1. The purpose
- In an effort to develop a new form of blood circulation enhancer which is useful in treatment and prevention of circulatory disorder, we aim to develop SPP-501 from earthworm.
2. The necessity
- As the nation i

Ⅰ. The purpose and necessity of the research and development
1. The purpose
- In an effort to develop a new form of blood circulation enhancer which is useful in treatment and prevention of circulatory disorder, we aim to develop SPP-501 from earthworm.
2. The necessity
- As the nation is becoming an aging society, there is a rapidly increasing number of patients with circulatory disorder. To treat diseases of the circulatory system, the development of a natural circulation enhancer that is very effective without side effects is urgently needed.

Ⅱ. Contents and scope of the research and development
- Obtainment of CMC data, toxicity and general pharmacological study, Completion of protocol for clinical trial, Application and approval of IND

Ⅲ. The results of the research and development
1. Obtaining data of domestic non-clinical studies
- Completion of single and repeated-dose toxicity study of rodent/non-rodent, toxicity, genetic toxicity test and general pharmacological study.
2. Efficacy test
- Completion of efficacy test
3. Obtainment of CMC data for IND filing
- Completion of obtaining data as to standard for analytical methods, formulation study and stability test.
4. Completion of clinical trial protocols for intermittent claudication
5. Approval of IND

Ⅳ. Application plan of the research results
- After obtaining scientific evidence to determine the effective dose, a phase Ⅲ clinical trial will be conducted and we will get commercial GMP certification. Finally, the result of this research will be released as a natural new drug.
- This will help to improve national health and the quality of life for people with circulatory disease.