Type of studies
- Single and repeated doses, dose escalating studies
- Immunosafety, immunogenicity
- Pulmonary tox and respiratory function
- Dose Range Finding (DRF)
- Maximum Tolerated Dose (MTD)
Type of test item
- Immunotherapies
- Antibodies, ADC, …
- Cell therapies, gene therapies, oncolytic virus
- Oligonucleotides, antisense oligonucleotides
- Therapeutic vaccines such as DNA vaccines, RNA vaccines
- Recombinant proteins, recombinant enzymes
- Peptides
- Oncolytic viruses (BSL2 biocontainment, GMO C2)
- Small molecules, ….
non-exhaustive list
