Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women

Summary

This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.

Timeline

Start

2017-10-01

Primary completion

2018-07-31

Completion

2018-09-01

Publications

• Teleshova N, Keller MJ, Fernandez Romero JA, Friedland BA, Creasy GW, Plagianos MG, Ray L, Barnable P, Kizima L, Rodriguez A, Cornejal N, Melo C, Cruz Rodriguez G, Mukhopadhyay S, Calenda G, Sinkar SU, Bonnaire T, Wesenberg A, Zhang S, Kleinbeck K, Palmer K, Alami M, O'Keefe BR, Gillevet P, Hur H, Liang Y, Santone G, Fichorova RN, Kalir T, Zydowsky TM. Results of a phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel. PLoS One. 2022 Jan 20;17(1):e0261775. doi: 10.1371/journal.pone.0261775. eCollection 2022.
• Shrivastava-Ranjan P, Lo MK, Chatterjee P, Flint M, Nichol ST, Montgomery JM, O'Keefe BR, Spiropoulou CF. Hantavirus Infection Is Inhibited by Griffithsin in Cell Culture. Front Cell Infect Microbiol. 2020 Nov 4;10:561502. doi: 10.3389/fcimb.2020.561502. eCollection 2020.

Drugs

Indications