Possibia

5574543

Last Update Posted: 2022-10-10

Recruiting has ended

All Genders

accepted

40 Years-80 Years

60 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

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

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.

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.

Eligibility

Relevant conditions:

Degenerative Disc Disease

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

No valid contacts available

Data sourced from ClinicalTrials.gov