A Clinical Study of AK115 in Healthy Subjects

Phase 1 Completed 42 enrolled Akeso

RandomizedSequentialQuadruple-blindTreatment

Summary

This trial is a randomized, double-blind, placebo-controlled dose escalation phase I trial following single dose subcutaneous administration of AK115 injection. It aims to evaluate the safety, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single dose of AK115 injection in healthy subjects.

Timeline

Start: 2022-03-18
Primary completion: 2022-09-28
Completion: 2022-09-28

Publications

Zhang J, Fan YX, Huang Y, Guan R, Li R, Long S, Yang M, Yu B, Wang GQ, Chen P, Gong X, Li B, Xia M, He J. The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administration of a Novel Anti-NGF Monoclonal Antibody (AK115) in Healthy Participants: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial. Drug Des Devel Ther. 2025 Apr 24;19:3225-3235. doi: 10.2147/DDDT.S500902. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LUVAGROBART	Monoclonal antibody	0.5 mg	Subcutaneous
Subject	LUVAGROBART	Monoclonal antibody	1 mg	Subcutaneous
Subject	LUVAGROBART	Monoclonal antibody	3 mg	Subcutaneous
Subject	LUVAGROBART	Monoclonal antibody	10 mg	Subcutaneous
Subject	LUVAGROBART	Monoclonal antibody	30 mg	Subcutaneous
Subject	LUVAGROBART	Monoclonal antibody	60 mg	Subcutaneous

Indications

No indication recorded.