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HM-002-1005 - A Phase 1, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Subjects With Type 2 Diabetes Mellitus
The purposes of this study are to:
* Evaluate the safety and tolerability of the study drug.
* Measure how much of the study drug (HM-002-1005) and its breakdown product get into the bloodstream, and how long it takes the body to get rid of them.
* Measure the amount of glucose (blood sugar) and a substance called C-peptide in the bloodstream after receiving the study drug.
Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug).
Participants will:
* Stay 5 days and 4 nights or 6 days and 5 nights at the research site, and have a follow-up phone call 7 days after leaving the research site.
* Take one (1) dose of the study drug or placebo
* Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide
* Have safety tests such as vital sign, ECGs, and glucose measurements
A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 With Additional 28-week Open-label Treatment to Evaluate the Safety of HMS5552 Alone in T2DM Subjects
This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.
A Multi-center, Randomized, Double-blind, Placebo-controlled, 12-week Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Population PK of HMS5552 in Type 2 Diabetic Adult Subjects
This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.
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