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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy men and women aged 18 to 45, with at least 3 people of the same gender in each group.
* BMI 19\~26 kg/m², men weigh ≥50 kg, women ≥45 kg.
* Voluntarily sign the informed consent form, fully aware of the research risks and procedures.
* Use reliable contraception for 3 months after the last dose, no plans for pregnancy or sperm/egg donation.
Exclusion Criteria:
* A family history of sudden death and serious neuropsychiatric disorders.
* Major underlying conditions like gastrointestinal absorption problems, chronic liver, kidney, heart, and endocrine diseases.
* Liver function, kidney function with eGFR\<90, abnormal QTc interval, positive for various infectious diseases.
* Drug allergies, drug abuse, recent participation in other clinical trials.
* Drinking alcohol, smoking, taking grapefruit/amino acid supplements, and having a chaotic routine during the screening period.
* Pregnant or breastfeeding women, people who can't tolerate blood draws or get faint from needles.
Primary outcome measure(s)
Adverse events and clinical safety indicators after a single dose. — Sign informed consent until Day3 discharge.
Change in QT/QTc interval correction ΔΔQTc after dosing. — Dynamic ECG monitoring from before to 24 hours after medication.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital).
Jinan
Shandong
Recruiting
More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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