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GenSci144 Tablets Phase I Clinical Trial
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
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.
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial in Healthy Adult Participants in China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of GenSci144
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-06-22
Completion Date
2026-12
Last Updated
2026-07-06
Healthy Volunteers
Yes
Conditions
Interventions
GenSci144 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.
GenSci144 placebo tablets
No active ingredients, appearance, excipients, and specifications are exactly the same as GenSci144.
Locations (1)
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital).
Jinan, Shandong, China