Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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MechanismTumor-associated glycoprotein 72 inhibitors |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 1/2 SCM-181注射液治疗特发性肺纤维化(IPF)患者的安全性、耐受性和初步有效性临床研究
[Translation] Clinical study on the safety, tolerability and preliminary efficacy of SCM-181 injection in the treatment of patients with idiopathic pulmonary fibrosis (IPF)
主要目的:评价不同剂量的SCM-181注射液静脉输注治疗特发性肺纤维化(IPF)患者的安全性和耐受性。
次要目的:评价不同剂量的SCM-181注射液静脉输注治疗特发性肺纤维化(IPF)患者的初步有效性,为后续临床研究推荐合适的治疗剂量。
探索性目的:探索SCM-181注射液静脉输注治疗特发性肺纤维化(IPF)患者的免疫相关指标。在多次给药剂量递增和扩展阶段将根据情况增加PK/同位素或其他探索性指标。
[Translation] Primary objective: To evaluate the safety and tolerability of different doses of SCM-181 injection for intravenous infusion in the treatment of patients with idiopathic pulmonary fibrosis (IPF).
Secondary objective: To evaluate the preliminary effectiveness of different doses of SCM-181 injection for intravenous infusion in the treatment of patients with idiopathic pulmonary fibrosis (IPF) and to recommend appropriate therapeutic doses for subsequent clinical studies.
Exploratory objective: To explore the immune-related indicators of SCM-181 injection for intravenous infusion in the treatment of patients with idiopathic pulmonary fibrosis (IPF). PK/isotope or other exploratory indicators will be added as appropriate in the multiple dose escalation and expansion phases.
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