GenSci144 Tablets Phase I Clinical Trial
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
Changchun GeneScience Pharmaceutical Co., Ltd.
48 participants
Jun 22, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07685210