🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

GenSci144 Tablets Phase I Clinical Trial

RecruitingPhase 1Ages 18 Years - 45 YearsAllChangchun GeneScience Pharmaceutical Co., Ltd.
NCT07685210 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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.
💊

What it tests

  • GenSci144 tablets
  • GenSci144 placebo tablets
📍

Where

1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital).
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy