Phase I

Milestones

Milestones and Milestone Events - Phase 1

1. Small Scale synthesis of Osteopura
2. Demonstrate that Osteopura prevents osteoporosis in an estrogen deficient model
3. Investigate the curative efficacy of Osteopura in an aged oestrogen deficient rat model of osteoporosis
4. Define toxicity
5. Demonstrate large scale synthesis and formulation to GMP
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6. Obtain ethical and regulatory authority to conduct Phase I human trial
7. Authorise GMP Osteopura drug production
8. Appoint CRO Clinical Trial facility, establish regulatory authority and ethical approval for Phase I human trial, recruit volunteers and randomise to blinded-cohorts
9. Commission drug production to GMP and get trial supply into signed hospital Pharmacy secure system
10. Complete all pre-clinical and clinical studies
 
Phase I