A Study of AST-008 in Healthy Subjects

Phase 1 Completed 16 enrolled Exicure, Inc.

SequentialOpen-labelScreening

Summary

AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.

Timeline

Start: 2017-10-20
Primary completion: 2018-08-16
Completion: 2018-08-16

Publications

Daniel WL, Lorch U, Mix S, Bexon AS. A first-in-human phase 1 study of cavrotolimod, a TLR9 agonist spherical nucleic acid, in healthy participants: Evidence of immune activation. Front Immunol. 2022 Dec 13;13:1073777. doi: 10.3389/fimmu.2022.1073777. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cavrotolimod	Oligonucleotide (other)	5 ug/kg	Subcutaneous
Subject	Cavrotolimod	Oligonucleotide (other)	10 ug/kg	Subcutaneous
Subject	Cavrotolimod	Oligonucleotide (other)	12.5 ug/kg	Subcutaneous
Subject	Cavrotolimod	Oligonucleotide (other)	18.8 ug/kg	Subcutaneous

Indications

No indication recorded.