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A Randomized, Double-blind, Placebo-Controlled, Repeat-Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of L47 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin
This is a randomized, double-blind, placebo-controlled, repeat-dose study to evaluate the safety, tolerability, PK, and PD of L47 as an add-on treatment to stable metformin therapy in patients with T2DM. Approximately 30 subjects will be randomized into the study at up to two investigational sites. The study includes a screening period of up to 28 days, with a three-day, single-blind, placebo lead-in period; a four-week, double-blind treatment period; and a one-week follow-up period. There will be 2 inpatient stays (Day -3 to 2 and 27 to 29) and daily outpatient visits during treatment period. During the follow-up period, there will be 1 outpatient visit at the end of the study. There will be 3 cohorts of 10 subjects each to be enrolled sequentially. In each cohort, subjects will be randomized in a 4:1 ratio to receive either L47 or placebo subcutaneously. Subjects will monitor fasting capillary glucose (finger sticks or self-monitoring of blood glucose, SMBG) during the lead-in, treatment, and follow-up periods.
注射用贺普拉肽治疗慢性丁型病毒性肝炎的多中心、随机、双盲、安慰剂平行对照IIa期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIa clinical trial of hepalatide for injection in the treatment of chronic hepatitis D virus
1)初步探索贺普拉肽治疗慢性丁型肝炎的有效性;
2)初步探索贺普拉肽治疗慢性丁型肝炎的安全性。
[Translation] 1) Preliminary exploration of the effectiveness of hepalatide in the treatment of chronic hepatitis D;
2) Preliminary exploration of the safety of hepalatide in the treatment of chronic hepatitis D.
Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D
100 Clinical Results associated with Shanghai HEP Pharmaceatical Co., Ltd.
0 Patents (Medical) associated with Shanghai HEP Pharmaceatical Co., Ltd.
100 Deals associated with Shanghai HEP Pharmaceatical Co., Ltd.
100 Translational Medicine associated with Shanghai HEP Pharmaceatical Co., Ltd.