Phase I trials

Phase I trials are conducted to provide initial indications about the safety of therapeutic interventions and, in the case of drugs, their pharmacodynamic and, pharmacokinetic properties. They involve a small number of subjects (typically 20 to 100), who are often healthy volunteers. In some areas, such as oncology, however, they may involve patients with the disease intended to be treated by the intervention, and so can also provide initial indications of therapeutic activity.

Latest Research and Reviews

  • Research |

    • Pamela Munster
    • , Ian E. Krop
    • , Patricia LoRusso
    • , Cynthia Ma
    • , Barry A. Siegel
    • , Anthony F. Shields
    • , István Molnár
    • , Thomas J. Wickham
    • , Joseph Reynolds
    • , Karen Campbell
    • , Bart S. Hendriks
    • , Bambang S. Adiwijaya
    • , Elena Geretti
    • , Victor Moyo
    •  & Kathy D. Miller
    British Journal of Cancer 119, 1086-1093
  • Research |

    Neoadjuvant combination immunotherapy in patients with advanced melanoma shows favorable activity over adjuvant treatment and warrants future evaluation with modified dosing schedules to reduce treatment-related adverse events.

    • Christian U. Blank
    • , Elisa A. Rozeman
    • , Lorenzo F. Fanchi
    • , Karolina Sikorska
    • , Bart van de Wiel
    • , Pia Kvistborg
    • , Oscar Krijgsman
    • , Marlous van den Braber
    • , Daisy Philips
    • , Annegien Broeks
    • , Johannes V. van Thienen
    • , Henk A. Mallo
    • , Sandra Adriaansz
    • , Sylvia ter Meulen
    • , Loes M. Pronk
    • , Lindsay G. Grijpink-Ongering
    • , Annemarie Bruining
    • , Rachel M. Gittelman
    • , Sarah Warren
    • , Harm van Tinteren
    • , Daniel S. Peeper
    • , John B. A. G. Haanen
    • , Alexander C. J. van Akkooi
    •  & Ton N. Schumacher
    Nature Medicine 24, 1655-1661
  • Research |

    Combination of two broadly neutralizing antibodies is effective in reducing HIV-1 viremia and in limiting the emergence of resistant viral variants in individuals harboring antibody-sensitive viruses.

    • Yotam Bar-On
    • , Henning Gruell
    • , Till Schoofs
    • , Joy A. Pai
    • , Lilian Nogueira
    • , Allison L. Butler
    • , Katrina Millard
    • , Clara Lehmann
    • , Isabelle Suárez
    • , Thiago Y. Oliveira
    • , Theodora Karagounis
    • , Yehuda Z. Cohen
    • , Christoph Wyen
    • , Stefan Scholten
    • , Lisa Handl
    • , Shiraz Belblidia
    • , Juan P. Dizon
    • , Jörg J. Vehreschild
    • , Maggi Witmer-Pack
    • , Irina Shimeliovich
    • , Kanika Jain
    • , Kerstin Fiddike
    • , Kelly E. Seaton
    • , Nicole L. Yates
    • , Jill Horowitz
    • , Roy M. Gulick
    • , Nico Pfeifer
    • , Georgia D. Tomaras
    • , Michael S. Seaman
    • , Gerd Fätkenheuer
    • , Marina Caskey
    • , Florian Klein
    •  & Michel C. Nussenzweig
    Nature Medicine 24, 1701-1707
  • Research |

    Combination therapy with the anti-HIV-1 monoclonal antibodies 3BNC117 and 10-1074 maintains long-term suppression in the absence of antiretroviral therapy in individuals with antibody-sensitive viral reservoirs.

    • Pilar Mendoza
    • , Henning Gruell
    • , Lilian Nogueira
    • , Joy A. Pai
    • , Allison L. Butler
    • , Katrina Millard
    • , Clara Lehmann
    • , Isabelle Suárez
    • , Thiago Y. Oliveira
    • , Julio C. C. Lorenzi
    • , Yehuda Z. Cohen
    • , Christoph Wyen
    • , Tim Kümmerle
    • , Theodora Karagounis
    • , Ching-Lan Lu
    • , Lisa Handl
    • , Cecilia Unson-O’Brien
    • , Roshni Patel
    • , Carola Ruping
    • , Maike Schlotz
    • , Maggi Witmer-Pack
    • , Irina Shimeliovich
    • , Gisela Kremer
    • , Eleonore Thomas
    • , Kelly E. Seaton
    • , Jill Horowitz
    • , Anthony P. West Jr
    • , Pamela J. Bjorkman
    • , Georgia D. Tomaras
    • , Roy M. Gulick
    • , Nico Pfeifer
    • , Gerd Fätkenheuer
    • , Michael S. Seaman
    • , Florian Klein
    • , Marina Caskey
    •  & Michel C. Nussenzweig
    Nature 561, 479-484
  • Research |

    Impaired NAD+ biosynthesis may be a common feature of high-risk hospitalizations for which NAD+ augmentation could improve therapeutic outcome.

    • Ali Poyan Mehr
    • , Mei T. Tran
    • , Kenneth M. Ralto
    • , David E. Leaf
    • , Vaughan Washco
    • , Joseph Messmer
    • , Adam Lerner
    • , Ajay Kher
    • , Steven H. Kim
    • , Charbel C. Khoury
    • , Shoshana J. Herzig
    • , Mary E. Trovato
    • , Noemie Simon-Tillaux
    • , Matthew R. Lynch
    • , Ravi I. Thadhani
    • , Clary B. Clish
    • , Kamal R. Khabbaz
    • , Eugene P. Rhee
    • , Sushrut S. Waikar
    • , Anders H. Berg
    •  & Samir M. Parikh
    Nature Medicine 24, 1351-1359

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