NCT04096105

Japanese Pharmacokinetic Bridging Study for CC-93538

A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of CC-93538 in Healthy Japanese and Caucasian Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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, safety, tolerability and immunogenicity of single SC doses of CC-93538 in healthy Japanese and Caucasian adult subjects. A total of approximately 48 subjects, 24 Japanese and 24 Caucasians, will be enrolled. Japanese subjects will be enrolled first and randomized 1:1 to receive a single SC dose of either 180 mg or 360 mg CC-93538. Caucasian subjects will then be enrolled and matched to Japanese subjects (1:1) by weight (± 20%) and receive the same single SC dose of either 180 mg or 360 mg CC-93538.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-93538	a single dose CC-93538 SC

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-01-29
• Completion: 2020-01-30
• First posted: 2019-09-19
• Last updated: 2020-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study