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A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects

NCT06387966 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-23

No results posted yet for this study

Summary

Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group.

Conditions

  • Heathly Subjects

Interventions

DRUG

Flonoltinib Maleate Tablets

Day 1 will be used for drug administration, and Day 1\~Day 7 will be used for experimental data collection.

DRUG

Flonoltinib Maleate Tablets placebo

Day 1 will be used for drug administration, and Day 1\~Day 7 will be used for experimental data collection.

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaolan Yong, bachelor · Chengdu Xinhua Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2024-08-15
Completion
2024-08-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06387966 on ClinicalTrials.gov