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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: Completed Phase 1 study, sponsored by Xentria.
NCT04971395 is a Phase 1 study that has completed, run by Xentria. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
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 |
What the finished NCT04971395 record still lists
NCT04971395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04971395 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04971395's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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