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Phase I clinical trials represent the first opportunity to evaluate the drug candidate clinically.
Phase I clinical trials are also called "First-In-Man" studies.
Phase I clinical trials using ribozyme gene therapy to treat AIDS patients have been conducted.
Phase I clinical trials are the first-time new therapies are given to people and usually include 15-30 patients.
Phase I clinical trials have tested sunitinib or pazopanib in combination with radiotherapy in patients with RCC or central nervous system (CNS) malignancies49,50.
Phase I clinical trials with CD40 agonists are being conducted on MM patients with encouraging results [46].
Phase I clinical trials followed from preclinical experiments, and these trials produce side effect profiles.
Phase I clinical trials for Leber congenital amaurosis (LCA), a rare, blinding retinopathy, established both indexes of safety and improved visual function, despite the small size and safety focus of first-in-human phase I clinical trials [ 6- 8].
CI-1017 has recently completed phase I clinical trials.
However, various vaccine candidates have already entered phase I clinical trials and have shown promising outcomes.
CK2 is a validated target for cancer therapy with one inhibitor in phase I clinical trials.
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