CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
VIS954 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06212804
NCT06212804Phase 1Completed
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A Phase 1, Randomized, Placebo-controlled, Double Blind, Single Ascending Dose, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Male and Female Participants

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 19, 2024·Updated Apr 24, 2026

In Brief

A Phase 1 clinical trial evaluating VIS954 and Placebo for Healthy Volunteers. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedJan 19, 2024
Enrollment StartNov 21, 2023
Primary CompletionJul 19, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.5 years ago

Interventions

VIS954biological

A humanized IgG4 monoclonal antibody.

Placeboother

VIS954 Placebo