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NCT04971395 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
A Phase 1 study, sponsored by Xentria.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT04971395 is a Phase 1 study that has completed, run by Xentria. The registered enrollment target is 25 participants.
The verdict
NCT04971395, a Phase 1 study, has completed, sponsored by Xentria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.
Interventions
- DRUG Placebo
- DRUG XTMAB-16 2 mg/kg
- DRUG XTMAB-16 4mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2022-03-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04971395
The ClinicalTrials.gov registry entry for NCT04971395 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xentria, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04971395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04971395 about?
NCT04971395 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants". This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.
What is the current status of trial NCT04971395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-06-25. Estimated completion is 2022-03-18.
What interventions are being tested in trial NCT04971395?
The interventions under investigation include: Placebo (DRUG), XTMAB-16 2 mg/kg (DRUG), XTMAB-16 4mg/kg (DRUG).
Who is sponsoring clinical trial NCT04971395?
This trial is sponsored by Xentria, which has 2 total clinical trials registered on ClinicalTrials.gov.
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