drugset
drugset / Trial / NCT05643248

To Assess Safety, Tolerability and PK of NEX-20A, a Subcutaneous Prolonged-release Injection to Healthy Subjects

NCT05643248 ↗

Phase 0 Completed 9 enrolled Nanexa AB CTC Clinical Trial Consultants AB · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a single-centre, single ascending dose (SAD) pilot study designed to evaluate the safety, tolerability, including local tolerability, and pharmacokinetics (PK) of NEX-20A (lenalidomide) after the administration of a single subcutaneous prolonged-release injection to healthy male volunteers

Timeline

Start
2022-11-28
Primary completion
2023-09-26
Completion
2023-09-26

Drugs

EvaluationDrugModalityDoseRoute
Subject NEX-20A Unknown 15 mg Subcutaneous
Subject NEX-20A Unknown 35 mg Subcutaneous
Subject NEX-20A Unknown 70 mg Subcutaneous
Subject NEX-20A Unknown 100 mg Subcutaneous

Indications

plasma cell myeloma