Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-24 @ 2:17 PM
Study NCT ID:
NCT04096105
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Pharmacokinetic Bridging Study for CC-93538
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1238-7252 | OTHER | WHO | View |