NCT03615196

Study of the Safety of USB005 in Healthy Volunteers

Evaluation of USB005 in a Phase 1 Normal, Healthy Volunteer Ocular Safety and PK Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: US Biotest, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-25
• Primary completion: 2018-11-08
• Completion: 2019-04-02
• First posted: 2018-08-03
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study