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Study of the Safety of USB005 in Healthy Volunteers

NCT03615196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-04-04

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • US Biotest, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Sheety, MD · WCCT Global, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-25
Primary Completion
2018-11-08
Completion
2019-04-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615196 on ClinicalTrials.gov