Abstract: Objective To investigate the agent and influencing factors of injection site pain following intramuscular injection of mouse nervous growth factor. Methods Randomized, double-blinded, parallel placebo controlled Phase to clinical trials. Results 4 of 8 health volunteers developed injection site pain in the phase 1, 32.56%(14/43) optic nerve contused wound subjects in the phase 2 clinical trial and 12.83%(39/304) in the phase 3 at the dose 30 g(15 000AU), which was recommended as clinical therapeutic dose. The duration and severity of the local pain varied in a dose-dependent manner. No life-threatening adverse events was seen at any dose. Conclusion s Injection site pain was the most frequent adverse event, but well tolerated at recommended dose. The pain was induced by mouse nerve growth factor and probably attenuated by prednisone.

Key words: mouse never growth factor, pain, clinical trial