Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

Phase 1 Completed 46 enrolled Innovent Biologics (Suzhou) Co. Ltd.

RandomizedSequentialDouble-blindTreatment

Summary

This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects

Timeline

Start: 2020-08-27
Primary completion: 2022-07-22
Completion: 2022-07-22

Publications

He J, Du W, Yang H, Wang J, Cai C, Ma Q, Li N, Yu J, Wu X, Wu J, Chen Y, Cao G, Zhang J. Safety and pharmacokinetics of IBI112, an IL-23 monoclonal antibody, in Chinese healthy volunteers: a first-in-human phase 1 study. Expert Opin Investig Drugs. 2023 Jul-Dec;32(7):669-675. doi: 10.1080/13543784.2023.2230122. Epub 2023 Jun 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IBI112	Monoclonal antibody	5 mg	Subcutaneous
Subject	IBI112	Monoclonal antibody	100 mg	Subcutaneous
Subject	IBI112	Monoclonal antibody	300 mg	Subcutaneous
Subject	IBI112	Monoclonal antibody	600 mg	Subcutaneous

Indications

No indication recorded.