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A Phase 1a/1b Clinical Trial Design To Assess Safety, Acceptability, Pharmacokinetics And Tolerability Of Intranasal Q-Griffithsin For Covid-19 Prophylaxis, Henry W. Nabeta, Maryam Zahin, Joshua L. Fuqua, Elizabeth D. Cash, Ingrid Leth, Michael Strauss, Jeanne Novak, Lin Wang, Angela Siegwald, Rachel A. Sheppard, Shesh N. Rai, Lisa C. Rohan, Sharon Hillier, Gerald W. Dryden, Kevin L. Potts, Kenneth E. Palmer
A Phase 1a/1b Clinical Trial Design To Assess Safety, Acceptability, Pharmacokinetics And Tolerability Of Intranasal Q-Griffithsin For Covid-19 Prophylaxis, Henry W. Nabeta, Maryam Zahin, Joshua L. Fuqua, Elizabeth D. Cash, Ingrid Leth, Michael Strauss, Jeanne Novak, Lin Wang, Angela Siegwald, Rachel A. Sheppard, Shesh N. Rai, Lisa C. Rohan, Sharon Hillier, Gerald W. Dryden, Kevin L. Potts, Kenneth E. Palmer
The University of Louisville Journal of Respiratory Infections
Background: The COVID-19 pandemic remains an ongoing threat to global public health. Q-Griffithsin (Q-GRFT) is a lectin that has demonstrated potent broad-spectrum inhibitory activity in preclinical studies in models of Nipah virus and the beta coronaviruses SARS-CoV, MERS-CoV, and SARS-CoV-2.
Methods: Here, we propose a clinical trial design to test the safety, pharmacokinetics (PK), and tolerability of intranasally administered Q-GRFT for the prevention of SARS-CoV-2 infection as a prophylaxis strategy. The initial Phase 1a study will assess the safety and PK of a single dose of intranasally administered Q-GRFT. If found safe, the safety, PK, and tolerability of multiple doses …