NCT05574543

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Angitia Biopharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	AGA111	AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
DRUG	Placebo	Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-07-13
• Completion: 2022-07-13
• First posted: 2022-10-10
• Last updated: 2022-10-10

Locations

6 sites across 1 country: China