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A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the Knee

2020-01-22 12:13:01 | BioPortfolio

Summary

A study to assess safety, tolerability and clinical effects of single and repeat dose intra-articular administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA).

Description

This is a randomized, double-blind, placebo-controlled study conducted as two parallel cohorts to assess the safety, tolerability, and clinical effects of single dose (SD) and repeat dose (RD) intra-articular (IA) administration of UBX0101 in patients with symptomatic knee osteoarthritis (OA).

Approximately 36 patients will be randomly assigned to either Cohort 1 (SD) or Cohort 2 (RD) (18 patients per treatment cohort) and further randomized in a 2:1 ratio to UBX0101 and placebo in each cohort.

The primary objective of the study is to evaluate the safety and tolerability of SD and RD IA administration of UBX0101 over 24 weeks.

Study Design

Conditions

Knee Osteoarthritis

Intervention

UBX0101, Placebo

Location

Premier Medical Associates
The Villages
Florida
United States
32159

Status

Recruiting

Source

Unity Biotechnology, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-22T12:13:01-0500

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