GenSci144 Tablets Phase I Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GenSci144 tablets, GenSci144 placebo tablets.
- Who it may be relevant to
- Registry conditions: Phenylketonuria. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug 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. - Drug GenSci144 placebo tablets
No active ingredients, appearance, excipients, and specifications are exactly the same as GenSci144.
Primary outcome measures
- 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.]
Secondary outcome measures (1)
- AUC0-t, AUC0-∞, Cmax, Tmax, t1/2, CL/F, Vz/F. [Time frame: From before dosing to 48 hours after dosing.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
China · 1 center
- The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Ho — Jinan
Identifiers
NCT: NCT07685210 · GenSci144-101