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New treatment option for Phenylketonuria
Official title GenSci144 Tablets Phase I Clinical Trial
ClinicalTrials.gov ID: NCT07685210
What this study is testing
What is GenSci144 tablets?
GenSci144 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for phenylketonuria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.