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

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.

Inclusion Criteria:

1. Willing and capable of giving signed informed consent.
2. Male or female, age between 40-80 years.
3. Male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization.
4. Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
5. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
6. Planning to receive single-level lumbar interbody fusion.
7. Willing and capable of adhering to the protocol and visit schedule.

Exclusion Criteria:

1. Prior surgical procedure at the involved or adjacent spinal levels.
2. Presence or prior history of inflammatory disease of the spine.
3. Presence or prior history of neoplastic disease of the spine.
4. BMI <18.5 or BMI >35.
5. Documented titanium allergy or intolerance.
6. Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
7. Presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study.
8. Active local or systemic infection.
9. Female subject who is pregnant or lactating.
10. Serological evidence of positive human immunodeficiency virus (HIV) antibody.
11. HBsAg positive or HBeAg positive, along with positive HBV DNA test.
12. Serological evidence of HCV antibody, along with HCV RNA > lower limit of detection.
13. Known drug or alcohol abuser.