NCT06387966

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

A Randomized, Double-blind, Placebo-controlled, Dose-escalating, Single-dose, Oral Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Adult Subjects in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2024-04-29
• Last updated: 2025-09-23

Locations

1 site across 1 country: China