ClinicalTrials.gov record NCT07685210

GenSci144 Tablets Phase I Clinical Trial

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 45 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase I trial gives single ascending oral doses of GenSci144 or matched placebo to healthy adults aged 18–45. It is randomized, double-blind, placebo-controlled and quadruple-masked. The main goals are to evaluate safety and tolerability and to measure pharmacokinetics and pharmacodynamics after a single dose.

What it is studying. The study tests the safety and tolerability of single ascending oral doses of GenSci144 in healthy adults and measures how the drug behaves in the body (pharmacokinetics) and its biological effects (pharmacodynamics). Data are intended to provide a basis for further clinical development related to phenylketonuria.

What the researchers hope to learn. To evaluate adverse events and clinical safety indicators after a single dose, to assess QT/QTc changes after dosing, and to characterize pharmacokinetic measures (AUC, Cmax, Tmax, t1/2, CL/F, Vz/F). To provide data to support subsequent clinical development for phenylketonuria.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • GenSci144 tablets
  • GenSci144 placebo tablets

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized, double-blind to receive a single oral dose of GenSci144 (or matching placebo) on an empty stomach (study includes single ascending dose levels such as 25 mg and 75 mg). They will stay under medical observation and be monitored for safety through Day 3, with dynamic ECG monitoring from before dosing to 24 hours after dosing and blood sampling for pharmacokinetics up to 48 hours after dosing. Screening involves health checks and lab tests (including pregnancy testing where applicable); participants must avoid alcohol, smoking, grapefruit, and amino acid supplements during the screening period. Participants must sign informed consent and agree to the contraception requirement after dosing.

How the study is structured. Participants are healthy adults who are randomly assigned to receive a single oral dose of GenSci144 at one of several dose levels or a matching placebo in parallel groups. The trial is double-blind and quadruple-masked. Participants undergo ECG monitoring (including up to 24 hours after dosing), safety assessments through Day 3, and blood sampling for pharmacokinetic measurements up to about 48 hours after dosing.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on phenylketonuria

Clinical trials38 trials listed for phenylketonuriaEvery trial the registry lists for phenylketonuria, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in phenylketonuria researchLatest monthly update: September 2026. Includes: Diet supply gaps. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 22, 2026
Primary completion
September 2026 (estimated)
Study completion
December 2026 (estimated)
Target enrollment
48 participants (estimated)
Last updated on registry
Jul 6, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital).Recruiting

    Jinan, Shandong, 250014 · China

Terms used on this page · explanations by MedicalUpdates.ai

ascending dose
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
double-blind
Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled
A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
pharmacokinetic
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamic
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
QTc
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
screening period
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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