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A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

Degenerative Disc Disease Clinical Trial

Official title:
A Randomized, Double-blinded, Placebo-controlled, Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Single Administration of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

Clinical Trial Summary

The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.

Clinical Trial Description

A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. A total of 60 participants will be enrolled and randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants will undergo lumbar interbody fusion and receive study treatment during the surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05574543
Study type Interventional
Source Angitia Biopharmaceuticals
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 1, 2020
Completion date July 13, 2022
View Details
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