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A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects

NCT06126562 ↗

Phase 1 Completed 24 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.

Timeline

Start
2023-10-31
Primary completion
2023-11-28
Completion
2023-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanifibranor Small molecule 800 mg —
Subject Lanifibranor Small molecule 1200 mg —

Indications

No indication recorded.