Zhuhai Beihai Biotechnology Co., Ltd.

The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).

This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer.

主要目的：Ⅰ期剂量探索研究：评估BH011注射液膀胱灌注治疗BCG治疗失败的高危NMIBC受试者的安全性和耐受性，确定最大耐受剂量（MTD）或Ⅱ期临床试验推荐剂量（RP2D）。Ⅱ期剂量扩展研究；评估BH011注射液膀胱灌注治疗BCG治疗失败的高危NMIBC受试者的有效性。