|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density
This is a placebo-controlled, single-ascending dose, multicenter Phase I clinical study to evaluate the safety, tolerability, PK and PD characteristics of a single intravenous infusion of TST002 in subjects with reduced bone mineral density.
评估TST002注射液在骨密度降低受试者的安全性和耐受性及药代动力学的Ⅰ期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of TST002 injection in subjects with reduced bone density
主要目的:评价TST002注射液的安全性和耐受性。次要目的:描述TST002注射液的药代动力学特征;评估TST002注射液的药效学特征;评价TST002注射液的免疫原性,评价其对PK和PD的可能影响;评价TST002的群体药代动力学,并评估TST002暴露量与药效学终点之间的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of TST002 injection. Secondary objectives: To describe the pharmacokinetic characteristics of TST002 injection; To evaluate the pharmacodynamic characteristics of TST002 injection; To evaluate the immunogenicity of TST002 injection and its possible effects on PK and PD; To evaluate the population pharmacokinetics of TST002 and to evaluate the relationship between TST002 exposure and pharmacodynamic endpoints.
100 Clinical Results associated with Hangzhou Just Biotherapeutics Co. Ltd.
0 Patents (Medical) associated with Hangzhou Just Biotherapeutics Co. Ltd.
100 Deals associated with Hangzhou Just Biotherapeutics Co. Ltd.
100 Translational Medicine associated with Hangzhou Just Biotherapeutics Co. Ltd.