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Population Council #728

Status
Completed
Phase
I
Objective

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

Prevention Option(s)
Microbicides
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
In the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer Griffithsin Gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home.
Mode of Delivery
Gel
Products
PC-6500
ARMs
Experimental
Description
In the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer placebo gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home.
Mode of Delivery
Gel
ARMs
Placebo Comparator
October 2017
September 2018
Enrollment
15
18
Years
49
Population
Women
Sites

Albert Einstein College of Medicine

Bronx, New York
United States of America