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NCT03097341 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects

A Phase 1 study, sponsored by Aronora.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT03097341: Completed Phase 1 study, sponsored by Aronora.

NCT03097341 is a Phase 1 study that has completed, run by Aronora. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03097341, a Phase 1 study, has completed, sponsored by Aronora.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of xisomab 3G3 in healthy adult subjects.

Primary Outcome

TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.

Interventions

  • OTHER Placebo
  • DRUG xisomab 3G3- Dose 1
  • DRUG xisomab 3G3-Dose 2
  • DRUG xisomab 3G3-Dose 3
  • DRUG xisomab 3G3- Dose 4

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2017-06-05
Est. Completion 2018-01-16
Phase Phase 1
Aronora

4 total trials

What the finished NCT03097341 record still lists

NCT03097341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT03097341 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03097341 about?

NCT03097341 is a clinical study titled "Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects". The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of xisomab 3G3 in healthy adult subjects.

What is the current status of trial NCT03097341?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-06-05. Estimated completion is 2018-01-16.

What interventions are being tested in trial NCT03097341?

The interventions under investigation include: Placebo (OTHER), xisomab 3G3- Dose 1 (DRUG), xisomab 3G3-Dose 2 (DRUG), xisomab 3G3-Dose 3 (DRUG), xisomab 3G3- Dose 4 (DRUG).

Who is sponsoring clinical trial NCT03097341?

This trial is sponsored by Aronora, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03097341's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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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Source: ClinicalTrials.gov NCT03097341, the US trial registry maintained by the National Library of Medicine. NCT03097341 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.