GenSci144 Tablets Phase I Clinical Trial

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Phenylketonuria

In brief

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.

Key facts

Study ID

NCT07685210

Run by

Changchun GeneScience Pharmaceutical Co., Ltd.

People needed

48

Starts

2026-06-22

Expected to finish

2026-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify 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 may not qualify 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.

Where it is running

• The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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