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NCT04373187 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT04373187 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 52 participants.
The verdict
NCT04373187, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study 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.
Interventions
- DRUG CC-93538
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04373187
The ClinicalTrials.gov registry entry for NCT04373187 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-93538 is the first listed.
NCT04373187 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04373187 about?
NCT04373187 is a clinical study titled "Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects". 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...
What is the current status of trial NCT04373187?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-06-22. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT04373187?
The interventions under investigation include: CC-93538 (DRUG).
Who is sponsoring clinical trial NCT04373187?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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