[Translation] A randomized, double-blind, parallel phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamics of TT-01688-CL in healthy subjects and patients with moderately to severely active ulcerative colitis
本试验分为A和B两部分。
A部分:
主要目的:
评价TT-01688-CL在健康受试者中的安全性。
次要目的:
评价TT-01688-CL在健康受试者中的PK特征。
评价TT-01688-CL在健康受试者中的PD生物标志物变化。
比较TT-01688-CL 1.5 mg固定剂量与1.5 mg滴定剂量对健康受试者心率的影响。
B部分:
主要目的:
评价TT-01688-CL在中重度活动性UC患者中的安全性。
次要目的:
评价TT-01688-CL在中重度活动性UC患者中的PK特征。
评价TT-01688-CL在中重度活动性UC患者中的PD生物标志物变化。
探索性目的:
在第3周治疗结束后,比较TT-01688-CL剂量组与安慰剂组对中重度活动性UC患者的症状应答和缓解(排便次数[Stool Frequency, SF]+直肠出血[Rectal bleeding, RB])。
其他疗效指标。
淋巴细胞亚型分析
[Translation] This trial is divided into two parts, A and B.
Part A:
Primary objective:
To evaluate the safety of TT-01688-CL in healthy subjects.
Secondary objective:
To evaluate the PK characteristics of TT-01688-CL in healthy subjects.
To evaluate the changes in PD biomarkers of TT-01688-CL in healthy subjects.
To compare the effects of TT-01688-CL 1.5 mg fixed dose and 1.5 mg titrated dose on heart rate in healthy subjects.
Part B:
Primary objective:
To evaluate the safety of TT-01688-CL in patients with moderately to severely active UC.
Secondary objective:
To evaluate the PK characteristics of TT-01688-CL in patients with moderately to severely active UC.
To evaluate the changes in PD biomarkers of TT-01688-CL in patients with moderately to severely active UC.
Exploratory objective:
After the third week of treatment, to compare the symptom response and relief (stool frequency [SF] + rectal bleeding [RB]) of patients with moderate to severe active UC between the TT-01688-CL dose group and the placebo group.
Other efficacy indicators.
Lymphocyte subtype analysis