This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Participants received escalating single doses of THDBH120 by subcutaneous injection.
Participants received single dose of placebo by subcutaneous injection.
Participants received multiple doses of THDBH120 once weekly for four weeks 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: From the first drug administration to the follow-up visit (57 days after the last drug administration)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
Time frame: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
Time frame: Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Evaluate the Fasting Blood Glucose (FBG ) of THDBH120
Time frame: Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD)
Number of Participants With Anti-THBHD120 Antibodies
Time frame: From the first drug administration to the follow-up visit (57 days after the last drug administration)
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Participants received placebo once weekly for four weeks by subcutaneous injection.