This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.
This is a Phase 1, single-center, randomized, double-masked, placebo-controlled, multiple ascending dose study in healthy volunteers. Thirty-two male and female volunteer subjects, between the ages of 18 and 64 years of age, will be enrolled. Subjects will be enrolled in four dose-escalating cohorts of eight subjects and randomized to USB005 or placebo in a ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration. The four cohorts will be identified as: Cohort 1(0.03% USB005 or placebo), Cohort 2 (0.1% USB005 or placebo), Cohort 3 (0.3% USB005 or placebo), and Cohort 4 (0.45% USB005 or placebo). Volunteers in the four cohorts will self-administer a single drop of USB005 or placebo into the study eye, three times a day for 28 days. The study eye in which the drug is applied to will be determined based on screening assessments. Subjects will be followed for 8 days after the last USB005 or placebo administration. The safety and tolerability of USB005 will be demonstrated by local toxicity, adverse events, laboratory assessments, vital signs, and a comprehensive eye exam. Plasma samples will be taken at various time points throughout the study to characterize the pharmacokinetics of USB005. Dropouts will be replaced after consultation with the Sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
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.
A clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution.
WCCT Global, Inc.
Cypress, California, United States
Percentage of volunteers with dose limiting toxicities in each cohort
Time frame: 36 days
Percentage of volunteers in each cohort with ocular adverse events
Time frame: 36 days
Percentage of volunteers in each cohort with systemic adverse events
Time frame: 36 days
Percentage of volunteers with clinically significant out of range laboratory values
Time frame: 36 days
Maximum observed concentrations (Cmax)
Time frame: 36 days
Time to reach maximum observed plasma concentration (Tmax) after multiple ascending dose
Time frame: 36 days
Apparent terminal half-life (T1/2) after multiple ascending dose
Time frame: 36 days
Area under the plasma concentration versus time curve from time 0 to infinity (AUCinf)
Time frame: 36 days
Area under the plasma concentration versus time curve up to the last measurable concentration (AUC0-last)
Time frame: 36 days
Apparent clearance (CL/F)
Time frame: 36 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.