The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with T2DM. This study includes three multiple-ascending dose cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
Participants received THDBH120 by subcutaneous injection.
Participants received placebo by subcutaneous injection.
Peking University First Hospital
Beijing, China
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Time frame: 78 days
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
Time frame: Day 1 Pre-dose through Day 43
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
Time frame: Day 1 Pre-dose through Day 43
Change From Baseline in HbA1C
Time frame: 43 days
Number of Participants With Anti-THBHD120 Antibodies
Time frame: 78 days
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