drugset

drugset / Trial / NCT03309605

Phase 1 Study of ELX-02 in Healthy Adult Subjects

NCT03309605 ↗

Phase 1 Completed 62 enrolled Eloxx Pharmaceuticals, Inc. SGS Life Sciences, a division of SGS Belgium NV · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase 1 Multiple Ascending Dose Study in Normal Healthy Volunteers

Timeline

Start: 2017-10-11
Primary completion: 2019-06-17
Completion: 2019-07-17

Publications

Results Leubitz A, Vanhoutte F, Hu MY, Porter K, Gordon E, Tencer K, Campbell K, Banks K, Haverty T. A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of ELX-02 in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Aug;10(8):859-869. doi: 10.1002/cpdd.914. Epub 2021 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ELX-02	Small molecule	0.1 mg/kg	Subcutaneous
Subject	ELX-02	Small molecule	0.3 mg/kg	Subcutaneous
Subject	ELX-02	Small molecule	1 mg/kg	Subcutaneous
Subject	ELX-02	Small molecule	2.5 mg/kg	Subcutaneous
Subject	ELX-02	Small molecule	5 mg/kg	Subcutaneous

Indications