This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics. In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
TQA3038 is an injection.
Placebo injection contains no active substance.
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGIncidence of adverse events (AEs) and serious adverse events (SAEs)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Up to 85 days.
Number of subjects with clinically significant abnormalities
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Time frame: Up to 85 days.
Maximum Plasma Concentration (Cmax)
Maximum concentration of TQA3038 and its metabolite in plasma
Time frame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Time to Reach Maximum Plasma Concentration (Tmax)
Time to reach Cmax of TQA3038 and its metabolite in plasma
Time frame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time
Time frame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Apparent Terminal Elimination Half-life (T1/2)
Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma
Time frame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Apparent Plasma Clearance (CL/F)
Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma
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Time frame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Fraction eliminated in the urine
Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma
Time frame: Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1.