Phase I Safety and Tolerability Study of Multiple Oral Dosing D-polymannuronicate Tablets in Healthy Volunteers

OBJEIVE: To assess the safety and tolerance of D-polymannuronicate in Chinese healthy volunteers. METHODS: The trial protocol was designed in accordance with the good clinical praice(GCP) of the State Drug Administration (SDA), and approved by the ethics committee of the General Hospital of PLA. Informed consent was obtained after all appropriate information had been given about the trial. A total of 29 healthy volunteers ranging from 18 to 55 years old were enrolled in the study. The subjes were randomly divided into 6 groups, including 100, 200,400, 500,600 and 700mg dosing groups, by 4 to 6 subjes in each group. Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic funions, renal funions, blood elerolytes, elerocardiogram, eleroencephalogram were observed or monitored. RESULTS: In all groups, no significant change was found in the clinical symptoms and laboratory examinations after dosing, except that transient acnes, headache and marked elevation of creatine kinase were observed in several volunteers. CONCLUSIONS: This study provided evidence that multiple oral doses of D-polymannuronicate to an amount of 500mg was safe and tolerable.