[Translation] Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of SS-001 ointment after single administration in healthy subjects and repeated administration in cancer patients with hand-foot syndrome (HFS)/hand-foot skin reaction (HFSR) induced by chemotherapy and multikinase inhibitors
第1部分:健康受试者单次给药剂量递增
主要目的:
评价SS-001软膏单次给药在健康受试者中的安全性和耐受性。
次要目的:
评价SS-001软膏单次给药在健康受试者中的药代动力学特征。
第2部分:患者多次给药剂量递增
主要目的:
评价SS-001软膏在接受化疗和多激酶抑制剂导致的HFS/HFSR癌症患者中多次给药的安全性和耐受性。
次要目的:
评价SS-001软膏在接受化疗和多激酶抑制剂导致的HFS/HFSR癌症患者中多次给药的药代动力学特征。
评价SS-001软膏在HFS/HFSR患者中的初步有效性。
探索性目的:
探索化疗和多激酶抑制剂导致的HFS/HFSR癌症患者在接受SS-001软膏多次给药后药效动力学的变化。
[Translation] Part 1: Single-dose escalation in healthy subjects
Primary objective:
To evaluate the safety and tolerability of a single dose of SS-001 ointment in healthy subjects.
Secondary objective:
To evaluate the pharmacokinetic characteristics of a single dose of SS-001 ointment in healthy subjects.
Part 2: Multiple-dose escalation in patients
Primary objective:
To evaluate the safety and tolerability of multiple doses of SS-001 ointment in patients with HFS/HFSR cancer who received chemotherapy and multi-kinase inhibitors.
Secondary objective:
To evaluate the pharmacokinetic characteristics of multiple doses of SS-001 ointment in patients with HFS/HFSR cancer who received chemotherapy and multi-kinase inhibitors.
To evaluate the preliminary efficacy of SS-001 ointment in patients with HFS/HFSR.
Exploratory objective:
To explore the changes in pharmacodynamics of SS-001 ointment in patients with HFS/HFSR cancer who received chemotherapy and multi-kinase inhibitors after multiple doses.