drugset / Trial / NCT04373187

Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects

NCT04373187 ↗

Phase 1 Completed 52 enrolled Celgene Corporation
RandomizedParallel-groupOpen-labelOther

Summary

This is an open-label, randomized, parallel design study to evaluate the PK comparability, safety, tolerability and immunogenicity of a single SC dose of 360 mg CC 93538 using two different drug concentrations, 180 mg/mL and 150 mg/mL, in healthy adult subjects. A total of approximately 52 subjects will be enrolled and randomized 1:1 to receive a single 360 mg SC dose of CC-93538 using either 180 mg/mL (1 injection of 2 mL) or 150 mg/mL (2 injections of 1.2 mL each) drug concentrations.

Timeline

Start
2020-06-22
Primary completion
2021-05-26
Completion
2021-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Cendakimab Monoclonal antibody 360 mg Subcutaneous

Indications

No indication recorded.