Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers

Phase 1 Completed 76 enrolled Allorion Therapeutics Inc

RandomizedSequentialDouble-blindTreatment

Summary

This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers.

Timeline

Start: 2023-08-29
Primary completion: 2024-03-28
Completion: 2024-03-28

Publications

Jin Z, Wu J, Liang J, Yang J, Sheng Q, Liu Z, Wang Y, Zhu C, Liu X, Liang W, Zhang X, Chen Y, Li J, Song Y, Wu X, Chen J, Ji T, Dong R. Development of a novel tyrosine kinase 2 inhibitor ARTS-011 and its first-in-human single and multiple ascending dose Phase I study to evaluate the tolerability, safety, pharmacokinetic profile and food effects. Br J Pharmacol. 2026 Jun;183(11):3074-3092. doi: 10.1111/bph.70338. Epub 2026 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARTS-011	Small molecule	3 mg	Oral
Subject	ARTS-011	Small molecule	10 mg	Oral
Subject	ARTS-011	Small molecule	20 mg	Oral
Subject	ARTS-011	Small molecule	40 mg	Oral
Subject	ARTS-011	Small molecule	60 mg	Oral

Indications

No indication recorded.