This study will comprise a randomized, double blind, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in subjects with type 2 diabetes mellitus (T2DM).
This study is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending-dose Phase Id/IIa clinical study in Chinese T2DM subjects after diet and exercise intervention and/or treatment with oral hypoglycemic agent to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of ZT002 injection in adult subjects with type 2 diabetes mellitus. Participants in each cohort will be randomized to receive a multiple SC doses of either ZT002 or matching placebo every 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Q2W, subcutaneous injection
Q2W, subcutaneous injection
Participants will receive the same volume as the study drug in each cohort.
The Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, China
Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.
Time frame: up to 155days
Area under the concentration-time curve at the end of dosing interval(τ) at steady state (AUC0-τ,SS)
Time frame: up to 155days
Time to Cmax at steady state (Tmax,ss)
Time frame: up to 155days
Steady-state peak concentration (Css_max), mean steady-state concentration (Css_av)
Time frame: up to 155days
Change from baseline of venous fasting plasma glucose
Time frame: up to 155days
Change from baseline of weight (kg).
Time frame: up to 155days
Incidence of anti-drug antibody against ZT002
Time frame: up to 155days
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