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NCT03815396 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
A Phase 1 study, sponsored by Inhibrx Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03815396 is a Phase 1 study that has completed, run by Inhibrx Biosciences. The registered enrollment target is 31 participants.
The verdict
NCT03815396, a Phase 1 study, has completed, sponsored by Inhibrx Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.
Interventions
- DRUG INBRX-101/rhAAT-Fc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03815396
The ClinicalTrials.gov registry entry for NCT03815396 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inhibrx Biosciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INBRX-101/rhAAT-Fc is the first listed.
NCT03815396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03815396 about?
NCT03815396 is a clinical study titled "Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency". This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 ...
What is the current status of trial NCT03815396?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2019-07-19. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT03815396?
The interventions under investigation include: INBRX-101/rhAAT-Fc (DRUG).
Who is sponsoring clinical trial NCT03815396?
This trial is sponsored by Inhibrx Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
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