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Japanese Pharmacokinetic Bridging Study for CC-93538
NCT04096105 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG CC-93538
Study Locations (1)
California
- Anaheim Clinical Trials — Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04096105
The ClinicalTrials.gov registry entry for NCT04096105 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention — of which CC-93538 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04096105 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04096105 about?
NCT04096105 is a clinical study titled "Japanese Pharmacokinetic Bridging Study for CC-93538". 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 subje...
What is the current status of trial NCT04096105?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-10-14. Estimated completion is 2020-01-30.
What conditions does trial NCT04096105 study?
This clinical trial studies the following conditions: Healthy Volunteers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04096105?
The interventions under investigation include: CC-93538 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04096105?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04096105 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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