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NCT06212804 · ClinicalTrials.gov registry record · Phase 1

A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants

A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target

NCT06212804 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 54 participants.

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The verdict

NCT06212804, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target

Study Summary

This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.

Interventions

  • OTHER Placebo
  • BIOLOGICAL VIS954

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2023-11-21
Est. Completion 2024-07-19
Phase Phase 1

What the Registry Record Tells You About NCT06212804

The ClinicalTrials.gov registry entry for NCT06212804 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT06212804 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06212804 about?

NCT06212804 is a clinical study titled "A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants". This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.

What is the current status of trial NCT06212804?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2023-11-21. Estimated completion is 2024-07-19.

What interventions are being tested in trial NCT06212804?

The interventions under investigation include: Placebo (OTHER), VIS954 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06212804?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.