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

HIV Infection Clinical Trial

Official title:
A Phase 1 Trial to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PC-6500 (Griffithsin [GRFT] in a Carrageenan Gel) in Healthy Women

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02875119
Study type Interventional
Source Population Council
Contact
Status Completed
Phase Phase 1
Start date October 1, 2017
Completion date September 1, 2018
View Details
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