[Translation] A phase Ib clinical study evaluating the safety, tolerability and pharmacokinetics of TB001 injection in patients with chronic viral hepatitis and liver fibrosis
主要目的:
在慢性病毒性肝炎伴肝纤维化患者中评估TB001注射液的安全性和耐受性。
次要目的:
在慢性病毒性肝炎伴肝纤维化患者中评估TB001注射液的药代动力学特征。
在慢性病毒性肝炎伴肝纤维化患者中评估TB001注射液的免疫原性特征。
在慢性病毒性肝炎伴肝纤维化患者中初步评估TB001注射后的潜在药效学特征。
[Translation] main purpose:
To evaluate the safety and tolerability of TB001 injection in patients with chronic viral hepatitis with liver fibrosis.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of TB001 injection in patients with chronic viral hepatitis and liver fibrosis.
To evaluate the immunogenicity characteristics of TB001 injection in patients with chronic viral hepatitis with liver fibrosis.
Preliminary evaluation of potential pharmacodynamic characteristics of TB001 after injection in patients with chronic viral hepatitis with liver fibrosis.