Study of the Safety of USB005 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 25, 2018

Primary Completion Date

November 8, 2018

Study Completion Date

April 2, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

USB005 (aclerastide) Ophthalmic Solution

Aclerastide (\[Nle3\]-Angiotensin II (1-7)) is aseptically formulated in USB005 Ophthalmic Solution for topical ophthalmic administration. Active pharmaceutical ingredient (API) levels ranging from 0.03% to 0.45% are formulated in a sterile vehicle consisting of 0.06% Sodium Phosphate Monobasic Anhydrous, USP; 3% Glycerol, USP; 1.4% Polyvinyl Alcohol, USP; and 0.5% Hydroxyethylcellulose (HEC 250 HHX), NF in Sterile Water for Injection, USP.

DRUG

USB005 Ophthalmic Solution Placebo

A clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution.

Trial Locations (1)

90630

WCCT Global, Inc., Cypress

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

US Biotest, Inc.

INDUSTRY

NCT03615196 - Study of the Safety of USB005 in Healthy Volunteers | Biotech Hunter | Biotech Hunter