NCT04373187

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

A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different Dose Concentrations of CC-93538 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-93538	one injection of 2mL
DRUG	CC-93538	two injections of 1.2mL

Timeline

• Start date: 2020-06-22
• Primary completion: 2021-05-26
• Completion: 2021-05-26
• First posted: 2020-05-04
• Last updated: 2021-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study