NCT04229225

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

A Double-Blind, Randomized, Placebo-Controlled Study of Single and Repeat Dose Administration of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Unity Biotechnology, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	UBX0101	Investigational drug intra-articular (IA) injection
OTHER	Placebo	Placebo intra-articular (IA) injection

Timeline

• Start date: 2020-01-23
• Primary completion: 2020-09-18
• Completion: 2020-09-18
• First posted: 2020-01-18
• Last updated: 2020-10-19

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study