Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
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|ClinicalTrials.gov Identifier: NCT02875119|
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Griffithsin Gel Drug: Placebo Gel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||September 1, 2018|
Experimental: Griffithsin Gel
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.
Drug: Griffithsin Gel
Griffithsin Gel is a large biologic molecule that is intended for vaginal rather than systemic administration. In addition, Griffithsin Gel is being developed for the prevention of HIV infection and not as a therapeutic agent. The concentration of Griffithsin Gel associated with prevention of HIV in vitro and in vivo has been established in non-clinical studies (see Section 5). Studies have demonstrated that Griffithsin Gel 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.
Placebo Comparator: Placebo Gel
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.
Drug: Placebo Gel
- Number and percent of participants with TEAEs, SAEs and AEs leading to premature discontinuation. [ Time Frame: 10 months ]To evaluate the safety of PC-6500 gel used vaginally for a single dose; and then for 14 consecutive days of dosing. AEs will be coded in accordance with the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
- Evaluation of the area under the time-concentration curve of Griffithsin gel in blood during and after dosing as assessed by (AUC0-last; AUC0-∞) [ Time Frame: 10 months ]To determine the PK of Griffithsin Gel in blood after a single dose, and then after 14 days of dosing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875119
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Study Chair:||George Creasy, MD||Population Council|