[Translation] A randomized, double-blind, placebo-controlled, phase I/II study to evaluate the safety and preliminary efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing intervertebral fusion
主要目的:
评估脊柱单节段椎体间单次给予AGA111的安全性。
次要目的:
评估脊柱单节段椎体间单次给予AGA111的药代动力学特征。
评估脊柱单节段椎体间单次给予AGA111的初步疗效。
[Translation] Primary purpose:
To evaluate the safety of single-dose administration of AGA111 at a single level between vertebrae in the spine.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of single-dose administration of AGA111 at a single level between vertebrae in the spine.
To evaluate the preliminary efficacy of single-dose administration of AGA111 at a single level between vertebrae in the spine.