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

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
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
GRFT
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
August 2018
Enrollment
36
18
Years
49
Years
Population
Women
Sites

Albert Einstein College of Medicine

Bronx, New York
United States of America