GenSci144 Tablets Phase I Clinical Trial

Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Study ID
NCT07685210
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • GenSci144 tablets — DRUG
    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.
  • GenSci144 placebo tablets — DRUG
    No active ingredients, appearance, excipients, and specifications are exactly the same as GenSci144.

Study Details

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 Dates

First listed
Jul 6, 2026
Start date
Jun 22, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: GenSci144 single-dose group.
  • Placebo Comparator: Matched placebo single-dose group.

Primary Outcome Measure

Adverse events and clinical safety indicators after a single dose. [ Time Frame: Sign informed consent until Day3 discharge. ]

Central Contacts

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