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NCT05909852 · ClinicalTrials.gov registry record · Phase 1
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
A Phase 1 study of Adalimumab, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 372
- Enrollment target
- 3
- Study locations
NCT05909852 is a Phase 1 study of Adalimumab that has completed, run by Amgen. The registered enrollment target is 372 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT05909852, a Phase 1 study of Adalimumab, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 372 participants
- Enrollment target
- 3
- Study locations
Study Summary
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.
Conditions Studied
Interventions
- DRUG ABP 501-HCF
- DRUG ABP 501-LCF
Study Locations (3)
California
- WCCT Global, Inc - Cypress
Florida
- Qps-Mra, Llc - South Miami
Utah
- Pharmaceutical Research Associates, Inc - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2021-07-23 |
| Est. Completion | 2021-11-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05909852
The ClinicalTrials.gov registry entry for NCT05909852 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adalimumab appearing as the primary indexed condition, and to 2 interventions - of which ABP 501-HCF is the first listed.
NCT05909852 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, Utah.
Frequently Asked Questions
What is clinical trial NCT05909852 about?
NCT05909852 is a clinical study titled "A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants". To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infin...
What is the current status of trial NCT05909852?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 372 participants. The study started on 2021-07-23. Estimated completion is 2021-11-24.
What conditions does trial NCT05909852 study?
This clinical trial studies the following conditions: Adalimumab.
What interventions are being tested in trial NCT05909852?
The interventions under investigation include: ABP 501-HCF (DRUG), ABP 501-LCF (DRUG).
Who is sponsoring clinical trial NCT05909852?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05909852 being conducted?
This trial has 3 study locations across California, Florida, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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