This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels. It was conducted using a randomized, double-blind, placebo-controlled design, primarily to evaluate the drug's safety and tolerability, while also exploring its pharmacokinetic and pharmacodynamic characteristics in the body, providing a basis for subsequent clinical use in the treatment of phenylketonuria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
48
SLC6A19 transporter small molecule inhibitor, oral tablets in 25mg and 75mg, given as a single dose on an empty stomach, used to explore treatment for phenylketonuria.
No active ingredients, appearance, excipients, and specifications are exactly the same as GenSci144.
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital).
Jinan, Shandong, China
RECRUITINGAdverse events and clinical safety indicators after a single dose.
Time frame: Sign informed consent until Day3 discharge.
Change in QT/QTc interval correction ΔΔQTc after dosing.
Time frame: Dynamic ECG monitoring from before to 24 hours after medication.
AUC0-t, AUC0-∞, Cmax, Tmax, t1/2, CL/F, Vz/F.
Time frame: From before dosing to 48 hours after dosing.
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