A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis

Phase 1 Completed 80 enrolled Akeso Biopharma, Inc.

RandomizedSequentialTriple-blindOther

Summary

A dose escalation, first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of AK120 in healthy subjects and subjects with moderate- to- severe atopic dermatitis

Timeline

Start: 2020-06-15
Primary completion: 2021-10-29
Completion: 2021-10-29

Publications

Wynne CJ, Cole A, Lemech C, Wang G, Zhang Y, Chen B, Wang M, Li B, Xia M, Sinclair R. Safety, Pharmacokinetics and Preliminary Efficacy of IL4-Ralpha Monoclonal Antibody AK120 in Both Healthy and Atopic Dermatitis Subjects: A Phase I, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, First-In-Human Clinical Study. Dermatol Ther (Heidelb). 2023 Oct;13(10):2357-2373. doi: 10.1007/s13555-023-01010-1. Epub 2023 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AK120	Monoclonal antibody	15 mg	Subcutaneous
Subject	AK120	Monoclonal antibody	50 mg	Subcutaneous
Subject	AK120	Monoclonal antibody	75 mg	Subcutaneous
Subject	AK120	Monoclonal antibody	150 mg	Subcutaneous
Subject	AK120	Monoclonal antibody	300 mg	Subcutaneous
Subject	AK120	Monoclonal antibody	600 mg	Subcutaneous

A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis

Summary

Timeline

Publications

Drugs

Indications