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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: Completed Phase 1 study, sponsored by Inhibrx Biosciences.
NCT03815396 is a Phase 1 study that has completed, run by Inhibrx Biosciences. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
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 |
What the finished NCT03815396 record still lists
NCT03815396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which INBRX-101/rhAAT-Fc is the first listed.
NCT03815396 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03815396's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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