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

NCT06212804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-24

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

VIS954

A humanized IgG4 monoclonal antibody.

OTHER

Placebo

VIS954 Placebo

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2024-07-19
Completion
2024-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212804 on ClinicalTrials.gov