A Phase 1 interventional study of GenSci144 tablets and GenSci144 placebo tablets in Phenylketonuria, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Other
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.
183 studies on the registry are indexed under Phenylketonurias; 38 are open to participants now.
This study's planned enrollment of 48 is above the median of 25 across 114 interventional studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: GenSci144 tablets
Drug: GenSci144 placebo tablets
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.
Adverse 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.
Urinary Hartnup amino acids, urinary phenylalanine and urinary glutamine.
Time frame: 24 hours before administration, 0-8 hours after administration, 8-24 hours after administration.
Plasma phenylalanine levels and plasma amino acid levels.
Time frame: Day-1 baseline, 1 hours, 2 hours, 3 hours, 4 hours, 24 hours after dosing.
Urine sodium and potassium levels.
Time frame: 0-8 hours and 8-24 hours after dosing.
urine output.
Time frame: - 24 to -16 hours, -16 to 0 hours before dosing, and 0-8 hours, 8-24 hours after dosing.
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Changchun GeneScience Pharmaceutical Co., Ltd.