NCT03513016

A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee

A Phase 1, Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety and Tolerability of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Unity Biotechnology, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.

Detailed description

This study is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study that will evaluate safety, tolerability, and pharmacokinetics of UBX0101 in patients diagnosed with painful femoro-tibial osteoarthritis. The study consists of 2 parts: Part A is a single ascending dose study, whereas Part B is a single-dose study at a dose that has been determined to be safe and tolerable in Part A of the study. In Part A, subjects will be randomly allocated to receive UBX0101 or placebo in 3:1 randomization by dose level (cohort), whereas in Part B subjects will be randomly allocated to receive UBX0101 or placebo in a 2:1 randomization. The primary objective is to establish the safety and tolerability of UBX0101 given as a single intra-articular injection into the femoro-tibial joint of patients with osteoarthritis.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	UBX0101	Investigational drug intra-articular injection
OTHER	Placebo	Diluent intra-articular injection

Timeline

• Start date: 2018-05-16
• Primary completion: 2019-03-29
• Completion: 2019-04-12
• First posted: 2018-05-01
• Last updated: 2020-04-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study