GenSci144 Tablets Phase I Clinical Trial
ConditionPhenylketonuria
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GenSci144 tablets
- GenSci144 placebo tablets
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov